BD HYPOINT¿ HYPODERMIC NEEDLE
Report
- Report Number
- 8041187-2023-00234
- Event Type
- Malfunction
- Date Received
- May 26, 2023
- Date of Event
- April 18, 2023
- Report Date
- June 5, 2023
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 00382903002535
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY THE CUSTOMER ISSUED A COMPLAINT FOR A MISMATCH BETWEEN THE CATALOGUE NUMBER ON LID LABEL AND COC RECEIVED. ONE (1) PHOTO WAS RECEIVED, ONE (1) TAX INVOICE FOR MATERIAL CODE 300253 & ONE (1) COC WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. FROM THE ABOVE INVESTIGATION, THE LID LABEL INFORMATION MATCHES OUR INTERNAL DRAWING DOCUMENTS AND THERE IS NO DISCREPANCY BETWEEN THE MATERIAL NUMBER ON THE COC AND THE SAP SYSTEM. BD-PS CONFIRMS THE NUMBER INDICATED IN THE LID LABEL UDI-DI(B)(4) CORRESPONDS TO THE UNIQUE DEVICE IDENTIFIER (UDI) FOR HYPOINT NEEDLE 25G X 5/8¿. THERE IS NO REQUIREMENT WHICH MENTIONS THAT THE NUMBER PRINTED ON THE LID LABEL MUST MENTION THE CATALOGUE NUMBER. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.
INVESTIGATION SUMMARY: THE CUSTOMER ISSUED A COMPLAINT FOR A MISMATCH BETWEEN THE CATALOGUE NUMBER ON LID LABEL AND COC RECEIVED. ONE (1) PHOTO WAS RECEIVED, ONE (1) TAX INVOICE FOR MATERIAL CODE 300253 & ONE (1) COC WERE PROVIDED TO BD MEDICAL ¿ PHARMACEUTICAL SYSTEM (BDM-PS) FOR ANALYSIS. BDM-PS PERFORMED A BATCH HISTORY RECORD¿S REVIEW (BHR) INCLUDING A REVIEW OF ALL DATA COLLECTED DURING IN PROCESS AND QUALITY INSPECTIONS. THE BATCHES INVOLVED IN THIS COMPLAINT MEET ALL ACCEPTABLE QUALITY LEVELS (AQL¿S), WERE MANUFACTURED AND RELEASED ACCORDING TO APPLICABLE PROCEDURES AND SPECIFICATIONS. BASED ON THE INVESTIGATION CONCLUSION, BDM-PS WAS NOT ABLE TO CONFIRM THE SYMPTOM PERCEIVED BY THE CUSTOMER OR CORRELATE THIS SYMPTOM WITH A POTENTIAL CAUSE LINKED TO BD PROCESS.
IT WAS REPORTED THAT THE CATALOG NUMBER OF THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS LISTED AS 300253 ON THE COC, WHILE IT WAS LISTED AS 3002535 ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONFIRMATION IS REQUIRED ON THE HIGHLIGHTED NUMBER MENTIONED IN THE IMAGE I.E., ¿3002535¿. IS THIS IS THE CATALOGUE NUMBER OR NOT? IF THIS IS THE CATALOGUE NUMBER, THEN IT IS NOT MATCHING WITH THE REQUIREMENT OF SPECIFICATION AND COC (CATALOGUE NUMBER IN SPECIFICATION AND VENDOR COC IS ¿300253¿)."
IT WAS REPORTED THAT THE CATALOG NUMBER OF THE BD HYPOINT¿ HYPODERMIC NEEDLE WAS LISTED AS 300253 ON THE COC, WHILE IT WAS LISTED AS 3002535 ON THE LABEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A CONFIRMATION IS REQUIRED ON THE HIGHLIGHTED NUMBER MENTIONED IN THE IMAGE I.E., ¿3002535¿. IS THIS IS THE CATALOGUE NUMBER OR NOT? IF THIS IS THE CATALOGUE NUMBER, THEN IT IS NOT MATCHING WITH THE REQUIREMENT OF SPECIFICATION AND COC (CATALOGUE NUMBER IN SPECIFICATION AND VENDOR COC IS ¿300253¿)."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1729685 | BD HYPOINT¿ HYPODERMIC NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 300253 | 0044266 | 00382903002535 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |