BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9%
Report
- Report Number
- 9616657-2020-00079
- Event Type
- Malfunction
- Date Received
- May 21, 2020
- Date of Event
- April 30, 2020
- Report Date
- June 18, 2020
- Manufacturer
- BECTON, DICKINSON AND CO.
- Product Code
- NGT
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 9192691. D.4. MEDICAL DEVICE EXPIRATION DATE:2022-06-30 . H.4. DEVICE MANUFACTURE DATE: 2019-07-11. D.4. MEDICAL DEVICE LOT #: 9248167. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31 . H.4. DEVICE MANUFACTURE DATE: 2019-09-05. D.4. MEDICAL DEVICE LOT #: 9255893. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. H.4. DEVICE MANUFACTURE DATE: 2019-09-12. H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBERS 9192691, 9255893, AND 9248167. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO PICTURE SAMPLES BELONGING TO LOT NUMBER 9192691 WERE RECEIVED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURES, THE PACKAGES WERE OBSERVED DAMAGED AND DEFECTIVE. THE EXACT CAUSE FOR THIS INCIDENT IS CURRENTLY BEING IDENTIFIED THROUGH AN ONGOING INVESTIGATION; HOWEVER, THIS ISSUE HAS BEEN ISOLATED TO PRODUCT MANUFACTURED USING ONE SINGLE PACKAGING LINE. THIS IS A KNOWN ISSUE RELATED TO A RECENT FIELD SAFETY NOTICE, AS PER (B)(4). IT IS UNDER INVESTIGATION AND IS BEING TRACKED BY CAPA 1472544. ALL AFFECTED PRODUCT HAS BEEN PLACED ON HOLD AND PRODUCTION HAS BEEN CEASED ON THE RESPONSIBLE PACKAGING LINE. OUR QUALITY TEAM IS CONTINUING TO INVESTIGATE THIS ISSUE FOR FURTHER CORRECTIVE AND PREVENTIVE ACTIONS.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE STERILITY WAS COMPROMISED. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FOLLOWING QUESTION WAS RECEIVED FROM A CUSTOMER: I WOULD LIKE TO ASK YOU IF THIS AFFECTS THE HEALTH/SAFETY OF THE PATIENTS? CAN THE TORN OPEN PACKAGES STILL BE USED OR NOT? IF NO, WHAT ABOUT THE REFUND OF THE DAMAGED SYRINGES? ON PROVIDED PICTURES PARTS OF THE PRODUCTS COME OUT OF THE PACKAGING CAN BE SEEN.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGES NACL 0.9% EXPERIENCED A DAMAGED OR OPEN UNIT PACKAGE WHERE STERILITY WAS COMPROMISED. IT HAS NOT BEEN SPECIFIED WHETHER THE PRODUCT DEFECT WAS NOTED PRIOR TO, DURING, OR AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE FOLLOWING QUESTION WAS RECEIVED FROM A CUSTOMER: I WOULD LIKE TO ASK YOU IF THIS AFFECTS THE HEALTH/SAFETY OF THE PATIENTS? CAN THE TORN OPEN PACKAGES STILL BE USED OR NOT? IF NO, WHAT ABOUT THE REFUND OF THE DAMAGED SYRINGES? ON PROVIDED PICTURES PARTS OF THE PRODUCTS COME OUT OF THE PACKAGING CAN BE SEEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 545038 | BD POSIFLUSH XS PRE-FILLED FLUSH SYRINGE NACL 0.9% | PREFILLED SALINE SYRINGE | NGT | BECTON, DICKINSON AND CO. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |