BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN
Report
- Report Number
- 1213809-2022-00092
- Event Type
- Malfunction
- Date Received
- February 22, 2022
- Date of Event
- February 9, 2022
- Report Date
- March 14, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903059035
- PMA / PMN Number
- K980580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 510(K)#: K951254. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: 510(K)#: K951254. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2022-MAR-07. INVESTIGATION SUMMARY: ONE PHYSICAL SAMPLE AND TWO PHOTOGRAPHS OF A 1ML SLIP-TIP SYRINGE WITH SAFETYGLIDE 25X5/8 NEEDLE (P/N 305903) WERE RECEIVED. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1097894 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.
IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN A STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMED.
IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN A STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMED.
IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN A STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: STOPPER DEFORMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 686295 | BD SAFETYGLIDE¿ NEEDLE 1-ML SYRINGE WITH 25-G X 5/8-IN | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 305903 | 1097894 | 30382903059035 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |