NEEDLE 18X1-1/2 SB
Report
- Report Number
- 1911916-2020-00883
- Event Type
- Malfunction
- Date Received
- September 21, 2020
- Date of Event
- September 10, 2020
- Report Date
- October 7, 2020
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMI
- UDI-DI
- 30382903051992
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: B.3. DATE OF EVENT: 2020-09-10. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. G.4. DATE RECEIVED BY MANUFACTURER: 2020-09-10.
H.6. INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305199 AND LOT NUMBER 9269108. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
IT WAS REPORTED THAT NEEDLE 18X1-1/2 SB PULLED OUT OF HUB. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305199; BATCH NO: 9269108. IT WAS REPORTED THAT: NEEDLE PULLED OUT OF HUB. EVENT DESCRIPTION PER EMAIL STATES: "OBTAINING MEDICATION PRE-PROCEDURE, RN ATTACHED A PINK NEEDLE TO A SYRINGE AND INSERTED SYRINGE INTO MEDICATION AND THE NEEDLE SEPARATED FROM THE PINK HUB WHICH WAS CRACKED AND THE NEEDLE REMAINED IN THE MEDICATION." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON (B)(6) 2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL (B)(6) 2020.
IT WAS REPORTED THAT NEEDLE 18X1-1/2 SB PULLED OUT OF HUB. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305199; BATCH NO: 9269108. IT WAS REPORTED THAT: NEEDLE PULLED OUT OF HUB. EVENT DESCRIPTION PER EMAIL STATES: "OBTAINING MEDICATION PRE-PROCEDURE, RN ATTACHED A PINK NEEDLE TO A SYRINGE AND INSERTED SYRINGE INTO MEDICATION AND THE NEEDLE SEPARATED FROM THE PINK HUB WHICH WAS CRACKED AND THE NEEDLE REMAINED IN THE MEDICATION." THE MEDWATCH REPORTED WAS RECEIVED IN FRANKLIN LAKES ON 23-APR-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE RCC UNTIL 09/17/2020.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 23 APRIL, 2020. MEDWATCH REPORT # (B)(4) REPORT SOURCE OTHER: MEDWATCH REPORT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).
IT WAS REPORTED THAT NEEDLE 18X1-1/2 SB PULLED OUT OF HUB. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 305199 BATCH NO: 9269108. IT WAS REPORTED THAT: NEEDLE PULLED OUT OF HUB. EVENT DESCRIPTION PER EMAIL STATES: "OBTAINING MEDICATION PRE-PROCEDURE, RN ATTACHED A PINK NEEDLE TO A SYRINGE AND INSERTED SYRINGE INTO MEDICATION AND THE NEEDLE SEPARATED FROM THE PINK HUB WHICH WAS CRACKED AND THE NEEDLE REMAINED IN THE MEDICATION." THE MEDWATCH REPORTED WAS RECEIVED IN (B)(4) ON 23-APR-2020 AND IT REFLECTED IN THE AWARENESS DATE. THE REPORT WAS NOT SENT TO THE (B)(4) UNTIL 09/17/2020.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1029053 | NEEDLE 18X1-1/2 SB | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 305199 | 9269108 | 30382903051992 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |