OnGuard®2 CSTD Bag Adaptor SP 412143Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 27290115921438), received between Sep 23, 2022 and Feb 3, 2026 — classified as 43 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (42 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 18, 2026.

Recalls naming this device

1. Mar 8, 2022Class IIOpen, Classified

   Disconnection of the OnGuard2 Bag Adaptor SP from infusion bags which may result in spillage of hazardous medications.

   Z-1057-2022 · Root cause: Equipment maintenance · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 43 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 3, 2026Disconnection; Fluid/Blood Leak

  CUSTOMER:(B)(4), (B)(6). (B)(6) 2025 WHEN DID THE FAILURE OCCUR: DURING THERAPY REASON OF COMPLAINT: WE HAD A PATIENT REPORT THAT HER 5FU PUMP WAS LEAKING AT THE CONNECTION SITE TO HER PORT. THE ORANGE PIECE CAME APART. DRUG SPILLED ON PATIENT AND BLOOD GOT INTO THE LINE. THE PATIENT WENT TO THE ER, AND THE ER SNAPPED IT BACK INTO PLACE, BUT THE PUMP HAD 47.9 ML REMAINING (~16 HOURS) AND WAS NOT CONTINUED. THE ORDER NUMBER IS X. THE PATIENT CAME BACK AT 11:45 TODAY TO GET A NEW CASSETTE ATTACHED FOR THE REMAINING DRUG PER DOCTOR'S REQUEST. CHARGE RN IS SUBMITTING AN INCIDENT AND WILL PROVIDE THE INCIDENT NUMBER WHEN SHE DOES SO. -FROM GS, PHARMD. MEDICATION COMPOUNDED BY PHARMACY TECH, ADMINISTERED BY RN FIRST CONTACT TO END CUSTOMER: B. BRAUN ADDITIONAL PATIENT INFORMATION: SPOKE WITH PT AFTER RECEIVING UPDATE FROM MD RE: PORT AND CONT 5FU ISSUES. PT REPORTS THAT APPROX 1930 SHE SAT DOWN ON COUCH AND HELD THE INFUSION TUBING SO SHE WOULD NOT SIT ON. SHE NOTICED AT THAT TIME THAT SHE HAD A FEW DROPS OF BLOOD AND CLEAR FLUID (5FU) IN HER HAND. PT STOPPED PUMP AND WASHED HANDS. PT HAD APPROX 13-14 HRS OF THE INFUSION LEFT. IT WAS ALSO NOTED THAT SHE HAD A SMALL WET AREA ON HER JACKET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243859 ↗
• MalfunctionFeb 3, 2026Disconnection; Fluid/Blood Leak

  WE ARE NOTIFYING YOU THAT WE HAVE RECEIVED ONE COMPLAINT SCAR-(B)(4) CC-(B)(4) FROM OUR CUSTOMER REGARDING YOUR PRODUCT. SPIKE PORT ADAPTOR LEAKAGE; SPIKE LOOSE; MATERIAL- 412143; BATCH- UBE654; NO SAMPLE; (B)(4) CUSTOMER (B)(6), EPIC CARE; WHEN DID THE FAILURE OCCUR: DURING PREPARATION. REASON OF COMPLAINT: HAVING ISSUES WITH REF: 412143 ONGARD BAG ADAPTOR, WHERE THE SPIKE IS SLIPPING OFF THE BAG AND CAUSING CHEMO SPILLS AND WASTE. RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER. RECORDED VIA- EMAIL. PATIENT INJURY- NO. ATTACHED INFORMATION- (B)(4) REGISTRATION FORM CUSTOMER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24243858 ↗
• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak

  WE ARE NOTIFYING YOU THAT WE HAVE RECEIVED ONE COMPLAINT, (B)(4) FROM OUR CUSTOMER REGARDING YOUR PRODUCT. SPIKE PORT ADAPTOR LEAKAGE; SPIKE LOOSE. MATERIAL-412166. BATCH-UBR522. NO SAMPLE. (B)(4). CUSTOMER (B)(4), (B)(6) OUTPATIENT PHARMACY. WHEN DID THE FAILURE OCCUR: DURING THERAPY. REASON OF COMPLAINT: IV SPIKE, (B)(4), CAME OUT WHEN ASSESSING SECURE CONNECTION ON ABRAXANE, MED SPILLED ON PUMP AND FLOOR. CLEANED SPILL AND NOTIFIED PHARMACY THAT A NEW BAG WAS NEEDED. NOTED. BASED ON DISPENSE PREPARATION IMAGES, APPEARS THAT ONGUARD2 BAG ADAPTOR WAS FULLY PUSHED INTO BAG PORT THOUGH ANGLES MAKE IT DIFFICULT TO CONFIRM WITH CERTAINTY. RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER. ATTACHED INFORMATION: OTHERS. PRODUCTS RELATED TO COMPLAINT. MANUFACTURER OF DISPOSABLE: SIMPLIVIA. ARTICLE / BATCH: 412166/UBR522. MANUFACTURER OF DRUG: AMERICAN REGENT, INC. NDC 0517-4300-01. ARTICLE / BATCH: ALBUMIN BOUND PACLITAXEL150MG, EXP 07/27/LOT 90038F0021. OTHERS: ICU MEDICAL. ARTICLE / BATCH: 100ML EMPTY BAG/LIST NO. 7951-23. PATIENT INJURY-NO. ATTACHED INFORMATION- (B)(4) REGISTRATION FORM CUSTOMER COMPLAINT PICTURE, NO SAMPLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232549 ↗
• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak

  WE ARE NOTIFYING YOU THAT WE HAVE RECEIVED ONE COMPLAINT (B)(4) FROM OUR CUSTOMER REGARDING YOUR PRODUCT. SPIKE LOOSE OR FALLS OUT. MATERIAL- 412143. BATCH- UBE657. NO SAMPLE. (B)(4). CUSTOMER (B)(6)), EPIC CARE. WHEN DID THE FAILURE OCCUR: DURING PREPARATION. REASON OF COMPLAINT: HAVING ISSUES WITH REF: (B)(4) ONGUARD BAG ADAPTOR, WHERE THE SPIKE IS SLIPPING OFF THE BAG AND CAUSING CHEMO SPILLS AND WASTE. RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER. PATIENT INJURY- NO. ATTACHED INFORMATION- (B)(4) REGISTRATION FORM CUSTOMER COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232318 ↗
• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak

  WE ARE NOTIFYING YOU THAT WE HAVE RECEIVED ONE COMPLAINT (B)(4), CC 400739359 FROM OUR CUSTOMER REGARDING YOUR PRODUCT. DESCRIPTION: CC 400739359, SPIKE LOOSE OR FALLS OUT, 412143 ON GUARD SPIKE PORT ADAPTOR, BATCH: UNKNOWN. CUSTOMER: (B)(6) (B)(6) SYSTEM ON (B)(6) 2025. GOOD MORNING, THE ON GUARD 2 CSTD BAG ADAPTOR 412143 FITS VERY LOOSELY IN ALL BBRAUN BAGS. IT IS PARTICULARLY LOOSE IN THE 500ML BAG. TODAY, THE SPIKE FELL OUT OF THE BAG CREATING A SIGNIFICANT SPILL OF THE ANTINEOPLASTIC. IT APPEARS THAT MY COLLEAGUES AT THE OTHER AHS SITES ARE HAVING SIMILAR ISSUES. I NEED TO TAKE ACTION IMMEDIATELY. CONSEQUENTLY, I APPRECIATE A PROMPT RESPONSE. RPH, MS, PHARMD, CCP PHARMACY DIRECTOR CENTRA STATE MEDICAL CENTER FREEHOLD, NJ 07728 ON (B)(6) 2025: CUSTOMER COMPLAINT ADVOCATE SEEMS TO HAVE BEEN ESCALATED - HAD A MEETING YESTERDAY. THEY NOTICED THIS WHEN THEY FIRST SWITCHED TO B. BRAUN BACK IN SEPTEMBER - WERE USING BAXTER AND FACILE...NOTICED THAT IT FIT VERY LOOSELY IN OUR BAGS - IN NON-B, BRAUN BAGS IS A TIGHT FIT. SOME MINOR LEAKS YESTERDAY A MAJOR LEAK - LUCKILY CONTAINED IN THE HOOD. CHEMO AGENT FELL ON STAFF (OPERATION PHARMACIST). AND IN THE PAST ON A NURSE - THIS WAS AT OVER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232203 ↗
• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak

  I AM NOTIFYING YOU THAT THE FOLLOWING COMPLAINT RECEIVED BY B. BRAUN IS FOR INFO ONLY. ONE COMPLAINT WAS WRITTEN FOR THE EVENT DESCRIPTION BELOW REGARDING PRODUCT NUMBER 412143, FOR "SPIKE PORT ADAPTOR LEAKAGE; SPIKE LOOSE" HOWEVER, THERE ARE NO SAMPLES, NO BATCH NUMBER, NO PICTURES SO NO SCAR RESPONSE IS REQUIRED - THIS IS FOR INFORMATION ONLY. THIS EMAIL SERVES AS NOTIFICATION OF THE FOLLOWING EVENTS AND NO FURTHER ACTION IS REQUIRED. (B)(6). WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION; DURING PREPARATION REASON OF COMPLAINT: WE'RE HAVING AN INTERMITTENT ISSUE OCCURRING WITH THE CLOSED SYSTEM SPIKES DISLODGING AS THE MEDICATION WAS INFUSING FOR A PATIENT. STAFF IS AWARE AND MAKES SURE EACH SPIKE PLACED IS HOLDING INITIALLY, SOME DON'T AND ARE DISCARDED BEFORE MIX IS MADE. HOWEVER, WE'RE HAVING OCCASIONS WHEN THEY GO OUT OF PHARMACY JUST FINE AND ARE DISLODGING AS NURSES IS HANGING THE MEDICATION OR DURING THE INFUSION. OF THE TWO THAT OCCURRED OVER THE PAST WEEK, ONE WAS INFUSING ON PATIENT WHEN SPIKE DETACHED AND THE OTHER WHEN NURSING WAS PRIMING FLUID FROM THE BAG FOR PREPARATION TO INFUSE. IN BOTH INSTANCES THE ENTIRE CONTENTS OF THE MEDICATION SPILLED OUT. DRUG ONE COST U

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24232166 ↗
• MalfunctionFeb 2, 2026Disconnection; Fluid/Blood Leak

  I AM NOTIFYING YOU THAT THE FOLLOWING COMPLAINT RECEIVED BY B. BRAUN IS FOR INFO ONLY. ONE COMPLAINT WAS WRITTEN FOR THE EVENT DESCRIPTION BELOW REGARDING PRODUCT NUMBER 412143, FOR "SPIKE DISLODGED FROM IV BAG IN TRANSPORT" HOWEVER, THERE ARE NO SAMPLES, NO BATCH NUMBER, NO PICTURES SO NO SCAR RESPONSE IS REQUIRED - THIS IS FOR INFORMATION ONLY. THIS EMAIL SERVES AS NOTIFICATION OF THE FOLLOWING EVENTS AND NO FURTHER ACTION IS REQUIRED. CC-400732199 CUSTOMER 20063402, STONY BROOK UNIVERSITY HOSPITAL WHEN DID THE FAILURE OCCUR: BEFORE APPLICATION REASON OF COMPLAINT: 412143 DISLODGED FROM IV BAG WHILE IN TRANSIT TO THE CANCER CENTER FROM PHARMACY RESPONSE EXPECTED BY: CUSTOMER; COMPLAINT RECEIVER PATIENT INJURY- NO ATTACHED INFORMATION 00116708 REGISTRATION FORM CUSTOMER COMPLAINT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24231479 ↗
• MalfunctionJun 8, 2025Air/Gas in Device; Air/Gas in Device

  I AM EMAILING TO GIVE SOME FEEDBACK ON SOME OF THE ISSUES WE HAVE BEEN HAVING WITH THE ON GUARD2 CLOSED SYSTEM TRANSFER DEVICE BAG ADAPTER SP. TODAY WE HAD THE ISSUE OF AN AIR LEAK IN/AROUND THE ADAPTER. THE BAG ADAPTER WAS SPIKED WITH THE TUBING AND THE ADAPTER WAS SPIKED INTO THE BAG AS IT SHOULD BE. WHILE SQUEEZING THE DRIP CHAMBER ON THE IV TUBING YOU COULD HEAR THE AIR ESCAPING THE TUBING FROM THE AREA OF THE BAG ADAPTER. WE ENSURED EVERYTHING WAS CORRECTLY CONNECTED AND EVEN CHANGED THE TUBING AND THE PROBLEM CONTINUED. WHILE PRIMING THE IV TUBING YOU COULD ALSO SEE THAT THERE WAS AN INCREASE IN BUBBLES COMING INTO THE LINE. THIS OBVIOUSLY COULD HAVE BEEN A SERIOUS ISSUE IF WE HAD SENT THIS OUT TO THE PATIENT AND AIR BUBBLES GOT INTO THE LINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22164397 ↗
• MalfunctionOct 25, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: ONGUARD 2 SPIKE PORT FELL OUT. DETAILED INQUIRY DESCRIPTION: THE SPILL OCCURRED WHEN THE NURSE REMOVED THE PRODUCT FROM THE SEALED TRANSPORT BAG IN FRONT OF THE PATIENT. THE PATIENT WAS NOT EXPOSED, BUT THE CARBOPLATIN SPILLED ON THE FLOOR. INJURY: NO.

  Patient problems: Chemical Exposure

  MAUDE report 15666325 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DETAILED INQUIRY DESCRIPTION: LEAKING ONGUARD SPIKE PORT ADAPTER LEAKED CHEMO PATIENT INVOLVED IN THE INQUIRY EVENT.

  Patient problems: Chemical Exposure

  MAUDE report 15621949 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: NEW ONGUARD SPIKE ADAPTOR 412143 FALLING OFF FROM BAG AND TIP OF DEVICE BROKEN DETAILED INQUIRY DESCRIPTION: WHILE SPIKING A BAXTER BAG THE TIP OF THE SPIKE ADAPTOR 412143 BROKE, ALSO THEY FOUND IT VERY SHARP AND SHORT AND THE BAXTER BAG GOT PERFORATED AND IT LEAKED. WHILE USING THE SPIKE ADAPTOR 412143 WITH (B)(6) PAB 500ML BAG THE SPIKE ADAPTOR FELT OFF AT THE BEDSIDE AND THE ONCOLOGY DRUG WAS ALL OVER THE NURSE AND PATIENT. WAS MEDICAL INTERVENTION NECESSARY- NO. WAS THERAPY INCOMPLETE, INCORRECT OR INTERRUPTED- NO. INJURY- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15621947 ↗
• MalfunctionOct 18, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: NEW ONGUARD 2 SPIKE PORT ADAPTOR LEAKING. DETAILED INQUIRY DESCRIPTION: INJURY: NO. USING THE DEVICE WITH 100ML NS PAB AND THEY EXPERIENCED LEAKAGE AROUND THE PAB PORT AFTER MANIPULATING THE SPIKE PORT ADAPTOR.

  Patient problems: Chemical Exposure

  MAUDE report 15621931 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  A PRODUCT COMPLAINT HAS BEEN ISSUE FOR THE DEFECTIVE ITEM. ITEM 412143 7 CS. DESCRIPTION: ITEM LEAKING. CUSTOMER OPEN 1CS AND USED THE 1BX ( 2BX/CS ) BUT 1BX WAS LEAKING. THEY STOPPED USING THE ENTIRE ORDER ( 7CS ).

  Patient problems: Chemical Exposure

  MAUDE report 15549370 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DETAILED INQUIRY DESCRIPTION: LEAKING ONGUARD SPIKE PORT ADAPTER LEAKED CHEMO. PATIENT INVOLVED IN THE INQUIRY EVENT- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15549368 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DETAILED INQUIRY DESCRIPTION: LEAKING ONGUARD SPIKE PORT ADAPTER LEAKED CHEMO PATIENT INVOLVED IN THE INQUIRY EVENT- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15549367 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DETAILED INQUIRY DESCRIPTION: LEAKING ONGUARD SPIKE PORT ADAPTER LEAKED CHEMO. PATIENT INVOLVED IN THE INQUIRY EVENT- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15549229 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: LEAKING SPIKE PORT ADAPTER. DETAILED INQUIRY DESCRIPTION: SPIKE PORT ADAPTER LEAKED WHEN CONNECTED TO IV BAG AND TUBING. WHEN DID EVENT OCCUR- WHILE COMPOUNDING ORDERS. INJURY- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15549223 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: NEW SPIKE ADAPTOR 412143 IS FALLING OFF THE PAB BAG. DETAILED INQUIRY DESCRIPTION. WHILE USING THE SPIKE ADAPTOR 412143 WITH B BRAUN PAB 500ML BAG THE SPIKE ADAPTOR FELT OFF DURING INSPECTION. ALSO THEY REPORTED THAT THE TIP OF THE SPIKE ADAPTOR BROKE DURING INSERTION. THE CUSTOMER ASKED WHY WE REMOVED THE LOCK.

  Patient problems: Chemical Exposure

  MAUDE report 15549221 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  CUSTOMER IS USING ONGUARD 2 SPIKE PORT ADAPTOR AND REPORTED THAT THE SPIKE ITSELF WAS LOOSE. THIS WAS NOTED IN THE PHARMACY. I BELIEVE THIS WAS BEFORE CHEMO WAS INVOLVED. PATIENT INVOLVED IN THE INQUIRY EVENT-NO DURING PREP. NO INJURY.

  Patient problems: Chemical Exposure

  MAUDE report 15549220 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION- LEAKING SPIKE PORT ADAPTERS. DETAILED INQUIRY DESCRIPTION- PHARMACY STATED THEY HAD A FEW ISSUES. PRODUCT INVOLVED IN THE INQUIRY EVENT- YES - DISPOSABLE. CUSTOMER REPORTED EVENT TO AUTHORITY- YES.

  Patient problems: Chemical Exposure

  MAUDE report 15549218 ↗
• MalfunctionOct 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  DETAILED INQUIRY DESCRIPTION: LEAKING ONGUARD SPIKE PORT ADAPTER LEAKED CHEMO PATIENT INVOLVED IN THE INQUIRY EVENT- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15549216 ↗
• MalfunctionOct 5, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: 412143 DISCONNECT. DETAILED INQUIRY DESCRIPTION: CUSTOMER HAD 2 INSTANCES OF 412143 DISCONNECTING FROM PACLITAXEL BAGS. WHEN DID EVENT OCCUR: IN PREPARATION/BEFORE USE. INJURY- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15545273 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION. INCIDENT WITH ONGUARD. DETAILED INQUIRY DESCRIPTION. THE NURSE WAS TRYING TO HANG THE BAG AND THE TUBING CAME OUT OF THE CHEMO AND THEN THE CHEMO SPILLED ALL OVER THE NURSE. IT'S APPARENTLY ALL BAG SIZES PHARMACIST TRIED DIFFERENT TYPES SIZES ETC BUT THE SPIKE JUST SEEMS TO COME OUT EASILY.

  Patient problems: Chemical Exposure

  MAUDE report 15527738 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  "WE JUST HAD TWO (2) OCCURRENCES OF SPIKES FALLING OUT OF THE IV PAB BAGS (50ML, 100ML) THIS MORNING". DURING PREP - INITIAL SPIKE OF THE BAG WITH SALINE, NO CHEMO SPILL, NO INJURY.

  Patient problems: Chemical Exposure

  MAUDE report 15527737 ↗
• MalfunctionOct 3, 2022Fluid/Blood Leak; Fluid/Blood Leak

  BRIEF INQUIRY DESCRIPTION: ONGUARD 2 SPIKE PORT ADAPTOR LOOSE FITTING AND FALLING OUT OF BAGS. DETAILED INQUIRY DESCRIPTION: 412143 SOMETIMES FEELS LOOSE WHEN INSERTED INTO B. BRAUN PAB 100ML BAGS AND 250 ML EXCEL BAGS, ONE INCIDENT WHERE THE SPIKE FELL OUT OF A PAB BAG WHEN IT WAS IN UNDER THE HOOD. INJURY- NO.

  Patient problems: Chemical Exposure

  MAUDE report 15527627 ↗