BD POSIFLUSH¿ NORMAL SALINE SYRINGE
Report
- Report Number
- 1911916-2023-00242
- Event Type
- Malfunction
- Date Received
- April 17, 2023
- Date of Event
- March 24, 2023
- Report Date
- May 10, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- NGT
- UDI-DI
- 00382903065462
- PMA / PMN Number
- K003553
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 306546 AND LOT NUMBER 2326216. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 09-MAY-2023. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE WOULD NOT FLUSH. TO AID IN THE INVESTIGATION, TWO EMPTY SAMPLES WITH NO PACKAGING FLOW WRAP OR TIP CAP WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND ALL RESULTS WERE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 2326216. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED AND A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WOULD NOT FLUSH COMPLETELY. THIS IS 2 OF 4 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A NURSE GIVE ME A SALINE FLUSH SYRINGE THAT WOULD NOT FLUSH. SEVERAL STAFF TRIED, INCLUDING MYSELF. SHE REPORTED THAT IT HAPPENED LAST WEEK AND SHE THOUGHT NOTHING OF IT, JUST A FLUKE. THEN IT HAPPENED AGAIN ON MONDAY. I DO HAVE THE SYRINGE. AT FIRST GLANCE IT LOOKS OKAY. SHE WAS ABLE TO FLUSH ABOUT 7 CC (NOTED WITH SOME DIFFICULTY) BUT THEN TOWARDS THE END, IT WOULDN'T FLUSH AT ALL. STAFF EVEN THOUGHT THE IV WAS BAD BECAUSE IT WOULDN'T FLUSH. IT LOOKS LIKE THE PLUNGER IS "DEFECTIVE" KIND OF BENT KEEPING IT FROM GOING FORWARD ANYMORE. I DID PUSH AND PULL AND EVENTUALLY WAS ABLE TO THEN MOVE THE PLUNGER. SHARING IN CASE OTHERS HAVE REPORTED THIS ISSUE WITH THE 10 ML BD PREFILLED SALINE SYRINGE. CS RESPONDED ON (B)(6). LOT 2326216 ON EACH SYRINGE GIVEN TO ME THE NURSE THOUGHT THE IV WAS BAD, RESTARTED IT. NO OTHER HARM.
IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WOULD NOT FLUSH COMPLETELY. THIS IS 2 OF 4 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A NURSE GIVE ME A SALINE FLUSH SYRINGE THAT WOULD NOT FLUSH. SEVERAL STAFF TRIED, INCLUDING MYSELF. SHE REPORTED THAT IT HAPPENED LAST WEEK AND SHE THOUGHT NOTHING OF IT, JUST A FLUKE. THEN IT HAPPENED AGAIN ON MONDAY. I DO HAVE THE SYRINGE. AT FIRST GLANCE IT LOOKS OKAY. SHE WAS ABLE TO FLUSH ABOUT 7 CC (NOTED WITH SOME DIFFICULTY) BUT THEN TOWARDS THE END, IT WOULDN'T FLUSH AT ALL. STAFF EVEN THOUGHT THE IV WAS BAD BECAUSE IT WOULDN'T FLUSH. IT LOOKS LIKE THE PLUNGER IS "DEFECTIVE" KIND OF BENT KEEPING IT FROM GOING FORWARD ANYMORE. I DID PUSH AND PULL AND EVENTUALLY WAS ABLE TO THEN MOVE THE PLUNGER. SHARING IN CASE OTHERS HAVE REPORTED THIS ISSUE WITH THE 10 ML BD PREFILLED SALINE SYRINGE. CS RESPONDED ON (B)(6). LOT 2326216 ON EACH SYRINGE GIVEN TO ME THE NURSE THOUGHT THE IV WAS BAD, RESTARTED IT. NO OTHER HARM.
IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE WOULD NOT FLUSH COMPLETELY. THIS IS 2 OF 4 RELATED EVENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAD A NURSE GIVE ME A SALINE FLUSH SYRINGE THAT WOULD NOT FLUSH. SEVERAL STAFF TRIED, INCLUDING MYSELF. SHE REPORTED THAT IT HAPPENED LAST WEEK AND SHE THOUGHT NOTHING OF IT, JUST A FLUKE. THEN IT HAPPENED AGAIN ON MONDAY. I DO HAVE THE SYRINGE. AT FIRST GLANCE IT LOOKS OKAY. SHE WAS ABLE TO FLUSH ABOUT 7 CC (NOTED WITH SOME DIFFICULTY) BUT THEN TOWARDS THE END, IT WOULDN'T FLUSH AT ALL. STAFF EVEN THOUGHT THE IV WAS BAD BECAUSE IT WOULDN'T FLUSH. IT LOOKS LIKE THE PLUNGER IS "DEFECTIVE" KIND OF BENT KEEPING IT FROM GOING FORWARD ANYMORE. I DID PUSH AND PULL AND EVENTUALLY WAS ABLE TO THEN MOVE THE PLUNGER. SHARING IN CASE OTHERS HAVE REPORTED THIS ISSUE WITH THE 10 ML BD PREFILLED SALINE SYRINGE. CS RESPONDED ON (B)(6). LOT 2326216 ON EACH SYRINGE GIVEN TO ME THE NURSE THOUGHT THE IV WAS BAD, RESTARTED IT. NO OTHER HARM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373285 | BD POSIFLUSH¿ NORMAL SALINE SYRINGE | SALINE, VASCULAR ACCESS FLUSH | NGT | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2326216 | 00382903065462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |