BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
Report
- Report Number
- 1911916-2023-00250
- Event Type
- Malfunction
- Date Received
- April 24, 2023
- Date of Event
- March 31, 2023
- Report Date
- April 25, 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
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 03-MAY-2023. IT WAS REPORTED PLUNGERS DISCONNECT FROM THE BLACK RUBBER PART INSIDE THE SYRINGE WHEN ASPIRATING. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING FLOW WRAP, TIP CAP, OR PLUNGER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 10X MAGNIFICATION, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED, INCLUDING WITH THE RUBBER STOPPER. THE SYRINGE BARREL HAS A RETAINING RING 1/8" FROM THE TOP THAT PREVENTS THE PLUNGER ROD FROM BREAKING OUT OF THE SYRINGE BARREL. NO DAMAGES WERE OBSERVED TO THE RETAINING RING. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THIS PRODUCT IS DESIGNED TO PUSH DOWN THE PLUNGER ROD TO EXPEL THE SOLUTION WHILE FLUSHING THE IV LINE. IT IS NOT DESIGNED FOR OTHER USES. IF THE PRODUCT IS NOT MEETING THE CUSTOMER¿S NEEDS, IT MAY BE BENEFICIAL TO CONTACT THE LOCAL BD SALES, OR MARKETING REPRESENTATIVE, FOR ADDITIONAL TRAINING OR PRODUCT OPTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 2241154. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. H3 OTHER TEXT : SEE H10.
B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, THE STOPPER SEPARATED FROM THE PLUNGER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED SOME OF THE SALINE FLUSHES, BOTH STERILE AND NON-STERILE, THAT HAVE LOOSE PLUNGERS AND ARE COMING APART WHEN ASPIRATING CENTRAL LINES. BELOW IS WHAT CLINICAL TEAM DESCRIBED OF THE ISSUE. MULTIPLE BD SYRINGES (STERILE AND UNSTERILE) SEEM TO HAVE LOOSE PLUNGERS THAT DISCONNECT FROM THE BLACK RUBBER PART INSIDE THE SYRINGE WHEN ASPIRATING OUR CENTRAL LINES. THESE ARE NORMALLY SCREWED IN PLACE AND IT SEEMS THEY HAVE BEEN MANUFACTURED LOOSELY AND ARE COMING APART.
IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, THE STOPPER SEPARATED FROM THE PLUNGER. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE NOTICED SOME OF THE SALINE FLUSHES, BOTH STERILE AND NON-STERILE, THAT HAVE LOOSE PLUNGERS AND ARE COMING APART WHEN ASPIRATING CENTRAL LINES. BELOW IS WHAT CLINICAL TEAM DESCRIBED OF THE ISSUE. MULTIPLE BD SYRINGES (STERILE AND UNSTERILE) SEEM TO HAVE LOOSE PLUNGERS THAT DISCONNECT FROM THE BLACK RUBBER PART INSIDE THE SYRINGE WHEN ASPIRATING OUR CENTRAL LINES. THESE ARE NORMALLY SCREWED IN PLACE AND IT SEEMS THEY HAVE BEEN MANUFACTURED LOOSELY AND ARE COMING APART.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1373176 | BD POSIFLUSH¿ NORMAL SALINE SYRINGES, | SALINE, VASCULAR ACCESS FLUSH | NGT | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 2241154 | 00382903065462 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |