BD POSIFLUSH NORMAL SALINE SYRINGE
Report
- Report Number
- 1911916-2020-00754
- Event Type
- Malfunction
- Date Received
- August 17, 2020
- Date of Event
- July 23, 2020
- Report Date
- August 27, 2020
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- NGT
- UDI-DI
- 30382903065470
- PMA / PMN Number
- K161552
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.
CORRECTION: THE PRODUCT GRID WAS UPDATED. THE FOLLOWING FIELDS HAVE BEEN CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE LEAKED BLOOD PAST THE PLUNGER DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. D.2. MEDICAL DEVICE LOT#: 0044900. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. H.4. DEVICE MANUFACTURE DATE: 2020-02-13.
IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE LEAKED BLOOD PAST THE PLUNGER DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " 3. DATE REPORTED (B)(6)2020 7:43 AM-MANUFACTURE NUMBER (B)(4). LOT NUMBER REPORTED 0042292. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO VASCULAR ACCESS 4. DATE REPORTED(B)(6)2020 7:44 AM MANUFACTURE NUMBER (B)(4). LOT NUMBER REPORTED 0044900. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO THE VASCULAR ACCESS.".
IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE LEAKED BLOOD PAST THE PLUNGER DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " 3. DATE REPORTED (B)(6) 2020 7:43 AM-MANUFACTURE NUMBER 306547. LOT NUMBER REPORTED 0042292. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO VASCULAR ACCESS 4. DATE REPORTED (B)(6) 2020 7:44 AM MANUFACTURE NUMBER 306547. LOT NUMBER REPORTED 0044900. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO THE VASCULAR ACCESS."
THE REPORTED LOT # [0042292] WAS NOT FOUND FOR THE REPORTED CATALOG # [306547]. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0044900, MEDICAL DEVICE EXPIRATION DATE: 2023-02-28, DEVICE MANUFACTURE DATE: 2020-02-13, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT 1 BD POSIFLUSH¿ NORMAL SALINE SYRINGE FROM LOT# 0044900, AND 1 SYRINGE FROM AN UNKNOWN LOT# LEAKED BLOOD PAST THEIR PLUNGERS DURING USE. THIS COMPLAINT WAS CREATED TO CAPTURE THE 3RD OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " DATE REPORTED (B)(6) 2020 7:43 AM MANUFACTURE NUMBER (B)(4). LOT NUMBER REPORTED 0042292. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO VASCULAR ACCESS. DATE REPORTED (B)(6) 2020 7:44 AM MANUFACTURE NUMBER (B)(4). LOT NUMBER REPORTED 0044900. ISSUE REPORTED BLOOD LEAKED FROM BEHIND THE PLUNGER WHILE INFUSING INTO THE VASCULAR ACCESS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 876572 | BD POSIFLUSH NORMAL SALINE SYRINGE | SALINE VASCULAR ACCESS FLUSH | NGT | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 306547 | 0044900 | 30382903065470 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |