BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN., STERILE
Report
- Report Number
- 1213809-2022-00045
- Event Type
- Malfunction
- Date Received
- February 3, 2022
- Date of Event
- January 14, 2022
- Report Date
- February 3, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903095972
- PMA / PMN Number
- K980580
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
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.
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.
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.4. MEDICAL DEVICE LOT #: 0150719. D.4. MEDICAL DEVICE EXPIRATION DATE: 4/30/2025. H.4. DEVICE MANUFACTURE DATE: 6/7/2020. 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 SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN., STERILE, SINGLE USE, 1 ML A NEEDLE BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309597 VERBATIM: SPOUSE REPORTS WHEN GOING TO USE 1 OF THE NEEDLES THE TOP BROKE OFF AND SOME OF THE MEDICATION WAS IN THE MISSING PART. SHE DISCARDED THAT NEEDLE AND USED A DIFFERENT ONE. SHE WANTED TO REPORT 1 DAMAGED NEEDLE. IS THE DATE OF EVENT KNOWN? (B)(6) 2022.
IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN., STERILE, SINGLE USE, 1 ML A NEEDLE BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309597 VERBATIM: SPOUSE REPORTS WHEN GOING TO USE 1 OF THE NEEDLES THE TOP BROKE OFF AND SOME OF THE MEDICATION WAS IN THE MISSING PART. SHE DISCARDED THAT NEEDLE AND USED A DIFFERENT ONE. SHE WANTED TO REPORT 1 DAMAGED NEEDLE. IS THE DATE OF EVENT KNOWN? (B)(6) 2022.
IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN., STERILE, SINGLE USE, 1 ML A NEEDLE BROKE OFF. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309597. VERBATIM: SPOUSE REPORTS WHEN GOING TO USE 1 OF THE NEEDLES THE TOP BROKE OFF AND SOME OF THE MEDICATION WAS IN THE MISSING PART. SHE DISCARDED THAT NEEDLE AND USED A DIFFERENT ONE. SHE WANTED TO REPORT 1 DAMAGED NEEDLE. IS THE DATE OF EVENT KNOWN? (B)(6) 2022.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1748586 | BD¿ LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE 26 G X 5/8 IN., STERILE | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 309597 | 0150719 | 30382903095972 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |