BD PhaSeal™ Optima 515057Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00382905150579), received between Jul 8, 2021 and Dec 16, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Recalls naming this device

1. Jun 16, 2025Open, Classified

   Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it.

   Z-2453-2025 · Root cause: Error in labeling · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 16, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23817277 ↗
• MalfunctionJul 3, 2025Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394458 ↗
• MalfunctionDec 30, 2024Disconnection; Disconnection

  MATERIAL # 515057, BATCH # UNKNOWN, 2312711. VERBATIM: I WAS MADE AWARE LATE YESTERDAY ABOUT THIS, AND WAS INFORMED THIS OCCURRED A FEW OTHER TIMES IN THE PAST: PLEASE SEE XXX'S EMAIL TO ME ON WHAT HAS OCCURRED..... HI XXX, WE HAVE ARE EXPERIENCING ISSUES WITH THE LOCKING PHASEAL. WE HAVE HAD 2 RECENT CHEMOTHERAPY SPILLS DUE THE PHASEAL DISCONNECTING FROM THE LINE. I INITIALLY THOUGHT IT WAS A ONE OFF, UNTIL A 2ND INCIDENT OCCURRED LAST WEEK AND ANOTHER TODAY. BECAUSE WE KNEW WE HAD AN ISSUE STAFF HAS BEEN VIGILANT ABOUT LOCKING THE PIECES ON. IN THE CASE TODAY IT APPEARED THAT THE PIECE WAS LOCKED ON, BUT WHEN PRESSURE WAS APPLIED IT EASILY DISCONNECTED. I INSPECTED IT AND KEPT GETTING THE SAME RESULT. WE ALSO HAD ONE INCIDENT WHERE THE PIECE DISCONNECTED AT THE PATIENT. THIS WAS A DRY DISCONNECT SO NO SPILL. HAS SOMETHING CHANGED WITH THE DEVICE? ALL INCIDENTS HAVE OCCURRED OVER THE PAST MONTH. ARE ANY OTHER SITES EXPERIENCING THE SAME ISSUE? THANKS, ADDITIONAL INFORMATION RECEIVED ON 27DEC. FOR INCIDENT "WHERE THE PIECE DISCONNECTED AT THE PATIENT" (NO LEAK). 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? 11/25/2024 2. CAN YOU PLEASE PROVIDE THE LOT NUMBE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044971 ↗
• MalfunctionDec 30, 2024Disconnection; Disconnection

  MATERIAL # 515057, BATCH # UNKNOWN, 2312711. VERBATIM: I WAS MADE AWARE LATE YESTERDAY ABOUT THIS, AND WAS INFORMED THIS OCCURRED A FEW OTHER TIMES IN THE PAST: PLEASE SEE XXX'S EMAIL TO ME ON WHAT HAS OCCURRED..... HI XXX, WE HAVE ARE EXPERIENCING ISSUES WITH THE LOCKING PHASEAL. WE HAVE HAD 2 RECENT CHEMOTHERAPY SPILLS DUE THE PHASEAL DISCONNECTING FROM THE LINE. I INITIALLY THOUGHT IT WAS A ONE OFF, UNTIL A 2ND INCIDENT OCCURRED LAST WEEK AND ANOTHER TODAY. BECAUSE WE KNEW WE HAD AN ISSUE STAFF HAS BEEN VIGILANT ABOUT LOCKING THE PIECES ON. IN THE CASE TODAY IT APPEARED THAT THE PIECE WAS LOCKED ON, BUT WHEN PRESSURE WAS APPLIED IT EASILY DISCONNECTED. I INSPECTED IT AND KEPT GETTING THE SAME RESULT. WE ALSO HAD ONE INCIDENT WHERE THE PIECE DISCONNECTED AT THE PATIENT. THIS WAS A DRY DISCONNECT SO NO SPILL. HAS SOMETHING CHANGED WITH THE DEVICE? ALL INCIDENTS HAVE OCCURRED OVER THE PAST MONTH. ARE ANY OTHER SITES EXPERIENCING THE SAME ISSUE? THANKS, ADDITIONAL INFORMATION RECEIVED ON 27DEC. FOR INCIDENT "WHERE THE PIECE DISCONNECTED AT THE PATIENT" (NO LEAK). 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? 11/25/2024. 2. CAN YOU PLEASE PROVIDE THE LOT NUMB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044885 ↗
• MalfunctionDec 30, 2024Disconnection; Disconnection

  MATERIAL # 515057. BATCH # UNKNOWN, 2312711. VERBATIM: I WAS MADE AWARE LATE YESTERDAY ABOUT THIS, AND WAS INFORMED THIS OCCURRED A FEW OTHER TIMES IN THE PAST: PLEASE SEE XXX'S EMAIL TO ME ON WHAT HAS OCCURRED..... HI XXX, WE HAVE ARE EXPERIENCING ISSUES WITH THE LOCKING PHASEAL. WE HAVE HAD 2 RECENT CHEMOTHERAPY SPILLS DUE THE PHASEAL DISCONNECTING FROM THE LINE. I INITIALLY THOUGHT IT WAS A ONE OFF, UNTIL A 2ND INCIDENT OCCURRED LAST WEEK AND ANOTHER TODAY. BECAUSE WE KNEW WE HAD AN ISSUE STAFF HAS BEEN VIGILANT ABOUT LOCKING THE PIECES ON. IN THE CASE TODAY IT APPEARED THAT THE PIECE WAS LOCKED ON, BUT WHEN PRESSURE WAS APPLIED IT EASILY DISCONNECTED. I INSPECTED IT AND KEPT GETTING THE SAME RESULT. WE ALSO HAD ONE INCIDENT WHERE THE PIECE DISCONNECTED AT THE PATIENT. THIS WAS A DRY DISCONNECT SO NO SPILL. HAS SOMETHING CHANGED WITH THE DEVICE? ALL INCIDENTS HAVE OCCURRED OVER THE PAST MONTH. ARE ANY OTHER SITES EXPERIENCING THE SAME ISSUE? THANKS. ADDITIONAL INFORMATION RECEIVED ON 27DEC. FOR INCIDENT "WHERE THE PIECE DISCONNECTED AT THE PATIENT" (NO LEAK). 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN MM-DD-YYYY FORMAT? (B)(6) 2024. 2. CAN YOU PLEASE PROVIDE THE LOT NUM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044884 ↗
• MalfunctionSep 6, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DURING THE PREPARATIONS OF HAZARDOUS DRUGS THERE WAS CONTAMINATION ON THE MEMBRANE. WHEN DID THE INCIDENT OCCUR? DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157209 ↗
• MalfunctionJun 21, 2024Disconnection; Disconnection

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19583029 ↗
• MalfunctionJun 6, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IFU DOES NOT INCLUDE THE DATE OF ISSUE OR DATE OF REVISION. ACCORDING TO EU REG. 2017/745 THE INSTRUCTIONS FOR USE SHALL CONTAIN, AMONG OTHERS, DATE OF ISSUE OF THE INSTRUCTIONS FOR USE OR, IF THEY HAVE BEEN REVISED, DATE OF ISSUE AND IDENTIFIER OF THE LATEST REVISION OF THE INSTRUCTIONS FOR USE. INITIAL USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19475608 ↗
• MalfunctionMay 22, 2024Break; Break

  MATERIALS#: UNKNOWN BATCH#: UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE JUST HAD A CONNECTOR BREAK. THE COLLAR AT THE TIP OF THE CONNECTOR CRACKED. PICTURES ATTACHED. LET US KNOW IF WE NEED TO DO ANYTHING ELSE. ADDITIONAL INFORMATION: 1. ARE YOU ABLE TO PROVIDE MATERIAL NUMBER AND BATCH / LOT NUMBER REPORTED? LOT# 2204302 2. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? NO ISSUES WITH THE PATIENT. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? THE NURSE DID GET DOCETAXEL ON HER HANDS, HOWEVER NO LONG TERM EFFECTS HAVE BEEN REPORTED. 4. ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. 05-16-2024 ALSO, THE CSTD IS STILL CONNECTED TO A BAG OF DOCETAXEL. WE DO NOT FEEL COMFORTABLE SHIPPING A BAG OF DOCETAXEL OUT. DUE TO THE BREAKAGE OF THE CONNECTOR, THERE IS HAZARDOUS CHEMO ON THE CONNECTOR AND THE BAG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370684 ↗
• MalfunctionOct 9, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

  MAT#: 515057; BATCH#: UNKNOWN. IT WAS REPORTED THAT THE PHASEAL OPTIMA INJECTOR CAME OFF THE LINE AT THE END OF TREATMENT. THEY ATTACH THE PHASEAL TO THE LINE WHEN THEY PRIME THEM. THEY SIT IN THE FRIDGE FOR UP TO 9 DAYS. ALSO, THEY ARE ABLE TO GET THEM OFF THE LINES. THIS IS NOT THE FAULT OF THE PHASEAL, BUT THE LINE. IF PULL BACK THE COLLAR, IT CAN GET THE PHASEAL OFF. VERBATIM: THE PHASEAL OPTIMA INJECTOR CAME OFF THE LINE AT THE END OF TREATMENT. WE ATTACH THE PHASEAL TO THE LINE WHEN WE PRIME THEM. THEY SIT IN THE FRIDGE FOR UP TO 9 DAYS. THIS WOULD NOT AFFECT ANYTHING, RIGHT? ALSO, WE ARE ABLE TO GET THEM OFF THE LINES. THIS IS NOT THE FAULT OF THE PHASEAL, BUT THE LINE. IF YOU PULL BACK THE COLLAR, YOU CAN GET THE PHASEAL OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17896364 ↗
• MalfunctionOct 6, 2023Fracture; Fracture

  MATERIAL#:515057 BATCH NUMBER#:2305310 IT WAS REPORTED BY CONSUMER THAT PRODUCT DEFECT THAT WAS CAUGHT BY ONE OF OUR NURSES (CLARE, CC¿D) ON 9/25. OUR PHARMACY COMPOUNDED A DOSE OF IRINOTECAN AND DISPENSED IT WITH THIS INJECTOR SECURED TO THE TUBING. THE NURSE CONNECTED NS IN PREPARATION FOR ADMINISTERING THE DOSE AND NOTICED THE LEAK AT THIS JOINT BEFORE UNCLAMPING THE CHEMO LINE. FORTUNATELY, NO IRINOTECAN ACTUALLY LEAKED BUT IT WAS CERTAINLY A NEAR-MISS. I WANT YOU TO BE AWARE OF THIS FOR ESCALATION AND REGISTERING THE APPROPRIATE QA INQUIRY INTERNALLY. VERBATIM: I AM REACHING OUT TO REPORT A PRODUCT DEFECT THAT WAS CAUGHT BY ONE OF OUR NURSES (B)(6), CC¿D) ON 9/25. OUR PHARMACY COMPOUNDED A DOSE OF IRINOTECAN AND DISPENSED IT WITH THIS INJECTOR SECURED TO THE TUBING. THE NURSE CONNECTED NS IN PREPARATION FOR ADMINISTERING THE DOSE AND NOTICED THE LEAK AT THIS JOINT BEFORE UNCLAMPING THE CHEMO LINE. FORTUNATELY, NO IRINOTECAN ACTUALLY LEAKED BUT IT WAS CERTAINLY A NEAR-MISS. I WANT YOU TO BE AWARE OF THIS FOR ESCALATION AND REGISTERING THE APPROPRIATE QA INQUIRY INTERNALLY. THANKFULLY THERE WAS NO INJURY OR HARM TO MYSELF OR THE PATIENT. THE CHEMOTHERAPY LINE WAS CLAMPED AND IT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17885311 ↗
• MalfunctionOct 2, 2023Break; Break

  IT WAS REPORTED THAT WHILE USING THE BD PHASEAL¿ OPTIMA INJECTOR WAS DEFECTIVE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: PATIENT HAD COMPLETED PACLITAXEL. WHEN THE NURSE WENT TO PULL THE PHASEAL OPTIMA INJECTOR OFF OF THE CONNECTOR, THE INJECTOR BROKE INTO 3 PIECES. ONE PORTION OF IT WAS STUCK TO THE CONNECTOR, SO THE NURSE HAD TO REMOVE THAT CONNECTOR, AND THEN ATTACH ANOTHER CONNECTOR SO SHE COULD PROCEED WITH THE PATIENT¿S NEXT CHEMOTHERAPY INFUSION. ADDITIONAL INFO RECEIVED ON 13-SEP-23. GOOD EVENING! FORTUNATELY, THE CHEMOTHERAPY HAD COMPLETED, SO THERE WAS NO HARM/IMPACT TO THE PATIENT. THE NURSE WAS WEARING APPROPRIATE PPE, SO THERE WAS NO HAZARDOUS DRUG EXPOSURE. I DO NOT BELIEVE ANY CHEMOTHERAPY SPILLED. I DID NOTICE A COUPLE OF DROPS OF CHEMOTHERAPY IN THE BIOHAZARD BAG THAT THE BROKEN DEVICE WAS PLACED IN. I'M ASSUMING IT WAS JUST THE SMALL RESIDUAL DRUG THAT WAS IN THE INJECTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17857930 ↗
• MalfunctionSep 28, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI) CRACKED AT THE THREADS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHASEAL OPTIMA INJECTOR CRACKED AT THE THREADS. NOT SURE IF THIS CRACKED WHEN PHARMACY PLACED ON THE LINE, OR WHEN IT WAS LOOKED AT BY NURSING. NO KNOWN EXPOSURE OR PATIENT IMPACT WITH THIS INCIDENT, BUT HAD POTENTIAL TO OTHER COMMENTS UNSURE IF THIS IS POSSIBLE DUE TO OVER TIGHTENING OR WHAT COULD CAUSE A CRACK IN THE THREADS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17836451 ↗
• MalfunctionSep 22, 2023Shielding Failure; Shielding Failure

  IT WAS REPORTED THAT THE NEEDLE WAS EXPOSED ON THE BD PHASEAL¿ OPTIMA INJECTOR N40-O MULTIPACK. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: RIGHT BEFORE DRAWING CHEMO WITH THE PHASEAL OPTIMA INJECTOR ATTACHED TO A SYRINGE, THE CUSTOMER NOTICED THE NEEDLE EXPOSED WITHIN THE OPTIMA INJECTOR. THEY SAW THAT THE INJECTOR LACKED AN INTERNAL MEMBRANE. THEY DID NOT SEE THE MEMBRANE INSIDE THE INJECTOR OR ANYWHERE IN THE HOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17804179 ↗
• MalfunctionAug 28, 2023Fluid/Blood Leak; Defective Component; Fluid/Blood Leak; Defective Component

  IT WAS REPORTED WHILE USING BD PHASEAL¿ OPTIMA INJECTOR N40-O THE DEVICE BROKE AND LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE RECENTLY HAD AN INCIDENT WITH INJECTOR BREAKING WHEN TECHNICIAN WAS ADDING THE CHEMO. UNFORTUNATELY, THEY DID NOT SAVE THE DEVICE FOR US TO EXAMINE. ¿ WHILE A TECHNICIAN WAS PREPARING TO DRAW UP CHEMO FROM THE VIAL, THE INJECTOR BROKE OFF CAUSING CHEMO TO SPILL IN THE HOOD AND SPLASH ON HER GOWN AND FLOOR. THIS OCCURRED AS SHE WAS INJECTING AIR INTO THE VIAL TO INFLATE THE EXPANSION CHAMBER ON THE PHASEAL PROTECTOR.¿

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638812 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI) BROKE INSIDE THE MCKESSON SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INJECTOR BROKE INSIDE MCKESSON SYRINGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17082469 ↗
• MalfunctionMay 16, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI) LEAKED CHEMOTHERAPY MEDICATION FROM THE DEFECTIVE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1881-PC ADRIAMYCIN DISPENSED BY PHARMACY AND VERIFIED BY TWO RNS AT CHAIRSIDE. PRIMARY RN CONNECTED THE ADRIAMCYIN SYRINGE TO AN NS BAG SET TO GRAVITY VIA A DRIPLESS CONNECTOR PER POLICY. ONCE THE RN ATTEMPTED TO ADMINISTER THE CHEMOTHERAPY, IT BEGAN FLOWING OUT OF THE CHEMO ADAPTER. THE ADAPTER WAS NOTED TO BE DEFECTIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16943011 ↗
• MalfunctionMar 4, 2023Break; Break

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA SYSTEM BROKE WHEN THE TECH WAS ATTEMPTING TO PUSH DRUG THROUGH THE INJECTOR. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OPTIMA LOCKING INJECTOR BROKE WHEN THE TECH WAS ATTEMPTING TO PUSH DRUG THROUGH THE INJECTOR. THE INJECTOR SNAPPED AT THE THREADS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16483411 ↗
• MalfunctionJun 16, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI) EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLINICIAN KNEW THERE WAS A LEAK BECAUSE WHEN THE MEDICATION IS EXPOSED TO AIR IT CRYSTALIZES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14720072 ↗
• MalfunctionAug 25, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BD PHASEAL OPTIMA INJECTOR (N40-O MULTI) HAD LEAKAGE ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NURSE NOTICED DRUG ON THE FLOOR AND DRIPPING FROM THE TUBING (ALARIS #11426964) TOWARDS THE END OF THE INFUSION. CHEMO WAS ADMINISTERED AT APPROX 500 ML/ HR WITH AN ALARIS PUMP. CUSTOMER FELT THAT THE LEAK OCCURRED BETWEEN THE SPIN COLLAR CONNECTION AND THE PHASEAL OPTIMA INJECTOR (PRODUCT 515057), WHICH HAD BEEN ATTACHED IN PHARMACY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367965 ↗
• MalfunctionJul 8, 2021Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A SMALL PIECE OF LOOSE "MEMBRANE" WAS FOUND ATOP THE BD PHASEAL¿ OPTIMA INJECTOR (N40-O MULTI) DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY NOTICED TINY PIECE (GRAIN OF SAND SIZE) OF LOOSE MEMBRANE MATERIAL (OR SOMETHING?) SITTING ON TOP OF P20-O PHASEAL OPTIMA PROTECTOR MEMBRANE WHEN DISCONNECTING THE INJECTOR AFTER DRAWING UP DRUG. I, THE REP SAW IT TOO. THIS HAPPENED 4 TIMES. ALL THE INJECTORS CAME FROM THE SAME MULTIPACK PACKAGE ETOPOSIDE ¿ TINY PIECE OF MEMBRANE OBSERVED ON TOP OF C100 PROTECTOR MEMBRANE AFTER DRAWING UP MEDICATION. IRINOTECAN ¿ 4 VIALS. PROTECTOR AND INJECTOR ON VIAL #4 HAVE SMALL VISIBLE HOLES FROM INJECTOR NEEDLE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. VELCADE ¿ SUBQ SYRINGE. AGAIN, A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ALIMTA ¿ 5 VIALS / RECONSTITUTED POWDER. FIRST ACCESS TO DILUENT BOTTLE HAD A TINY PIECE OF MEMBRANE OBSERVED ON TOP OF PROTECTOR MEMBRANE. ADAPTER MEMBRANE ON BAG HAD A LOT OF SHINE AFTER DRUG WAS ADDED WITH THE INJECTOR THAT HAD BEEN ENGAGED 6 TIMES AT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12140351 ↗