BD PosiFlush SureScrub 306559Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00382903065592), received between Jun 8, 2018 and Feb 23, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (10 reports).

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.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2023Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SURESCRUB¿ PRE-FILLED SYRINGE SOLUTION WAS DISCOLORED AND CLOUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "SYRINGE WITH STERILE SALINE REMOVED FROM THE DISPENSARY WITH CLOUDY LIQUID".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16427491 ↗
• MalfunctionFeb 17, 2023Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE BD POSIFLUSH¿ SURESCRUB¿ PRE-FILLED SYRINGE HAD NO LABEL ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "NO IMPRESSION ON THE CYLINDER BODY... AS THERE WAS NO PRINT ON THE SYRINGE, IT WAS NOT POSSIBLE TO IDENTIFY THE BATCH."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16393994 ↗
• MalfunctionSep 3, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SYR 10ML SURE SCRUB POSIFLUSH SALINE TIP WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT ONE SYRINGE FOUND WITH MANGLED TOP THAT WOULD NOT ALLOW FOR LEUR-LOCK AND HAD CHIPS OF PLASTIC COMING OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422578 ↗
• MalfunctionAug 14, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYR 10 ML SURESCRUB POSIFLUSH SALINE EXPERIENCED DIFFICULT PLUNGER MOVEMENT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME OF THE SYRINGES THAT HAVE THE ALCOHOL PAD IN THE PLASTIC WITH THE SALINE ARE HAVING PROBLEMS. WHEN INJECTING, THE SYRINGE CATCHES AROUND 2-4 ML MARK AND BECOMES VERY DIFFICULT TO CONTINUE INJECTING. IT SEEMS TO BE STICKING AND TAKES A FAIR AMOUNT OF FORCE TO OVERCOME IT. MULTIPLE NURSES TODAY REPORTED THAT THEY THOUGHT THERE WERE ISSUES WITH THEIR CATHETERS/LINES, BUT WHEN THEY ATTEMPTED TO FLUSH WITH THE "OLDER" SYRINGES THAT DO NOT HAVE ALCOHOL PADS WITH THEM, THE CATHETERS WERE COMPLETELY FINE. THERE IS CONCERN THIS COULD CAUSE SOMEONE TO POSSIBLY ALTEPLASE A LINE THAT DID NOT NEED TO BE BECAUSE IT IS TOO SLUGGISH FOR DIALYSIS I CHECKED MEDSUN AND THERE ARE NO RECALLS FOR THE PRODUCT BD POSIFLUSH SURESCRUB 0.9% SODIUM CHLORIDE INJECTION. I HAVE NO OTHER REPORTS OF THIS OCCURRING ANYWHERE ELSE IN OUR SYSTEM. I'M NOT SURE IF THIS IS A ONE OFF OR PROBLEMS WITH A LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10411648 ↗
• MalfunctionOct 1, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD POSIFLUSH¿ SURESCRUB PRE-FILLED SYRINGE WOULD CEASE UP. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306559 BATCH NO.: 9136939. IT WAS REPORTED THAT THE PRE-FILLED SYRINGE WOULD CEASE UP BECAUSE THE STOPPER WOULD STICK AND THE BARREL OF THE SYRINGE WAS TAPERED. PR 2 OF 2: THIS PR IS FOR INCIDENT THAT OCCURRED "WE HAD AN ISOLATED ISSUE LAST WEEK " WE HAVE 52 BOXES OF 30 EACH WITH THE SAME LOT. WE HAD AN ISOLATED ISSUE LAST WEEK AND THE SAME ISSUE AROSE AGAIN TODAY 3 TIMES. 2 WERE BACK TO BACK. WHEN THE IV WAS STARTED AND THE NURSES WERE GOING TO FLUSH, THE PREFILLED SYRINGES WOULD CEASE UP. THE STOPPER WOULD STICK AROUND THE 7-8MM SPOT. IT IS ALMOST LIKE THE SYRINGE WAS TAPERED NOT TO ALLOW THE PLUNGER TO ADVANCE ANY FURTHER. WE ONLY HAVE 1 BOX OF 30 ON OUR SHELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140790 ↗
• MalfunctionOct 1, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD POSIFLUSH¿ SURESCRUB PRE-FILLED SYRINGE WOULD CEASE UP. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 306559, BATCH NO.: 9136939. IT WAS REPORTED THAT THE PRE-FILLED SYRINGE WOULD CEASE UP BECAUSE THE STOPPER WOULD STICK AND THE BARREL OF THE SYRINGE WAS TAPERED. PR 1 OF 2: THIS PR IS FOR INCIDENT THAT OCCURRED "AND THE SAME ISSUE AROSE AGAIN TODAY 3 TIMES." WE HAVE 52 BOXES OF 30 EACH WITH THE SAME LOT. WE JUST RECEIVED 2 CASES ON IT TODAY. WE HAD AN ISOLATED ISSUE LAST WEEK AND THE SAME ISSUE AROSE AGAIN TODAY 3 TIMES. 2 WERE BACK TO BACK. WHEN THE IV WAS STARTED AND THE NURSES WERE GOING TO FLUSH, THE PREFILLED SYRINGES WOULD CEASE UP. THE STOPPER WOULD STICK AROUND THE 7-8MM SPOT. IT IS ALMOST LIKE THE SYRINGE WAS TAPERED NOT TO ALLOW THE PLUNGER TO ADVANCE ANY FURTHER. WE ONLY HAVE 1 BOX OF 30 ON OUR SHELF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9140373 ↗
• MalfunctionAug 15, 2019Leak/Splash; Leak/Splash

  MATERIAL NO. 306559 BATCH NO. UNKNOWN IT WAS REPORTED THAT DURING USE OF THE SYR 10ML SURESCRUB POSIFLUSH SALINE THERE IS LEAKAGE AT THE PLUNGER THIS OCCURRED ON 7 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THERE IS LEAKAGE AT THE PLUNGER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8897051 ↗
• MalfunctionJun 19, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PLUNGER SEPARATED WITH A BD SYR 10ML SURESCRUB POSIFLUSH SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2). MATERIAL NO: 306559, BATCH NO: 8362820. IT WAS REPORTED THAT PLUNGER SEPARATES FROM SYRINGE. PER CUSTOMER EMAIL: ONE SYRINGE OUT OF THE BOX THAT DID POP OFF PRE-MATURELY. USED THE WHOLE BOX EXCEPT FOR 2 SYRINGES. SEEMS TO THINK THIS WAS MUCH BETTER AS WITH THE OTHER LOT SYRINGES, IT WAS HAPPENING VERY FREQUENTLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8713741 ↗
• MalfunctionJun 6, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT OCCURRED WITH A R 10ML SURESCRUB POSIFLUSH SALINE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THAT WEN PULLING BACK ON ROD AFTER FLUSHING, THE ROD COMPLETELY COMES OUT WITH A BIG POP NOISE. PER CUSTOMER EMAIL: I JUST GO OUT OF A MEETING AT THE ACCOUNT. THEY USE ANYWHERE FROM ~600-700 OF (306559)/DAY. AFTER INTERACTING WITH A HANDFUL OF THE NURSES, IT BECAME CLEAR THAT THIS IS HAPPENING WAY MORE OFTEN THAN WE KNEW ABOUT- THE NURSES HAVEN'T BEEN REPORTING IT. IT HAS BEEN HAPPENING SEVERAL TIMES A DAY PER NURSE ON THESE UNITS: BMT, RADIOLOGY, CRC/TREATMENT (WHERE I TALKED TO A FEW NURSES ON EACH UNIT). ONE OF THE NURSES EVEN SHOWED ME ON OF THEIR PATIENTS WHAT WAS HAPPENING. SHE IS ABLE TO FLUSH ALL THE WAY AND THEN WHEN PULLING BACK ON THE ROD TO CHECK FOR BLOOD RETURN THE ROD COMPLETELY COMES OUT WITH A BIG ¿POP¿ NOISE (BOTH SCARY FOR THE NURSE AND PATIENTS). SHE MENTIONED THAT SHE ORIGINALLY THOUGHT IT WAS MAYBE UNLUCKY OR VARYING TECHNIQUE THAT WAS THE PROBLEM, BUT THIS HAPPENS SEVERAL TIMES A DAY AND WHEN ASKING THE GROUP OF NURSES AT THE NURSES STATION THEY ALL GO ¿OH YEAH, THIS HAPPENS ALL THE TIME.¿ A HAVE A HANDFUL OF

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8675694 ↗
• MalfunctionJun 4, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SYR 10ML SURESCRUB POSIFLUSH SALINE LEAKED IN THE SEALED PACKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LIQUID LEAKED/EXPLODED"

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8667645 ↗
• MalfunctionMay 3, 2019Leak/Splash

  IT WAS REPORTED THAT THE SYR 10ML SURESCRUB POSIFLUSH SALINE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306559 BATCH NO: 8261703 EVENT DESCRIPTION PER ATTACHED EMAIL STATES, "WE HAD A SALINE FLUSH TODAY, SAME LOT 8261703, IN WHICH THE SALINE CAME OUT TOWARD THE NURSES BY THE PLUNGER END. WE WILL ENTER AN SI, BUT WANTED TO LET YOU ALL KNOW AS WELL. "

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8579783 ↗
• MalfunctionApr 24, 2019Loose or Intermittent Connection; Defective Device

  IT WAS REPORTED THAT FOUR SYR 10ML SURESCRUB POSIFLUSH SALINE EXPERIENCED LOOSE PLUNGERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 306559, LOT NO: 8261704. PER PHONE CALL: NURSE REPORTED THAT WHEN PULLING BACK TO DRAW BLOOD FROM PORT PLUNGER CAME APART FROM THE SYRINGE. NURSE STATED SHE HAD IT HAPPEN 4 TIMES WITHIN THE LAST WEEK. PER CUSTOMER EMAIL RX FROM USER FACILITY, CALLED IN TO REPORT DEFECTIVE POSIFLUSH SYRINGES. THE PLUNGERS ARE FALLING APART AND ARE WOBBLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8545226 ↗
• MalfunctionApr 9, 2019Leak/Splash

  IT WAS REPORTED THAT DURING USE OF THE BD ¿ PRE-FILLED NORMAL SALINE SYRINGE WAS LEAKING OUT OF THE DISTAL "PLUNGER" END OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306559 BATCH. 8261703 "NURSE WENT TO FLUSH A PERIPHERAL IV LINE, AND FOUND THAT THE POSIFLUSH SALINE SYRINGE WAS LEAKING OUT OF THE DISTAL "PLUNGER" END OF THE SYRINGE. *THIS LEAKING COULD RESULT IN ADDITIONAL STAFF EXPOSURE TO HAZARDOUS DRUGS. THIS EVENT WAS ORIGINALLY REPORTED ON (B)(6) 2019, AND WAS REPORTED A SECOND TIME ON (B)(6) 2019. LOT # 8261703 WHAT WAS THE ORIGINAL INTENDED PROCEDURE? FLUSHING OF IV DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;."

  Patient problems: No Information

  MAUDE report 8496157 ↗
• MalfunctionApr 9, 2019Fluid/Blood Leak

  IT WAS REPORTED THAT DURING USE OF THE BD ¿ PRE-FILLED NORMAL SALINE SYRINGE WAS LEAKING OUT OF THE DISTAL "PLUNGER" END OF THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 306559, BATCH. 8261703. "NURSE WENT TO FLUSH A PERIPHERAL IV LINE, AND FOUND THAT THE POSIFLUSH SALINE SYRINGE WAS LEAKING OUT OF THE DISTAL "PLUNGER" END OF THE SYRINGE. *THIS LEAKING COULD RESULT IN ADDITIONAL STAFF EXPOSURE TO HAZARDOUS DRUGS. THIS EVENT WAS ORIGINALLY REPORTED ON (B)(6) 2019, AND WAS REPORTED A SECOND TIME ON (B)(6) 2019. LOT # 8261703. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? FLUSHING OF IV. DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO;."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8496032 ↗
• MalfunctionJun 8, 2018Activation, Positioning or Separation Problem; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING USE A BD ¿ PRE-FILLED NORMAL SALINE SYRINGE MALFUNCTIONED AS " THE MEDFUSION SYRINGE PUMPS ARE HAVING TROUBLE RECOGNIZING THE LOML BD PRE- FILLED FLUSHES. THE PUMP WILL READ "INVALID SYRINGE SIZE" AND RESEATING THE FLUSH DOES NOT WORK. THE CHANGE IN THE PLUNGER WHEN POSIFLUSH CAME OUT CAUSED INCREASED DRAG AND THEREBY INCREASED PRESSURE UPON DEPLOYMENT OF THE FLUID." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7583730 ↗