BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE
Report
- Report Number
- 8041187-2022-00247
- Event Type
- Malfunction
- Date Received
- May 11, 2022
- Date of Event
- April 20, 2022
- Report Date
- August 15, 2022
- Manufacturer
- BECTON DICKINSON MEDICAL (SINGAPORE)
- Product Code
- FMI
- UDI-DI
- 30382903057802
- PMA / PMN Number
- K161170
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THERE WERE MULTIPLE DEVICE NAMES/TYPES AND 510K NUMBERS REPORTED TO BE INVOLVED. ADDITIONAL INFORMATION BELOW: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K)#: K941562 . A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY: ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE PLUNGER IS WITHDRAWN TO THE APPROXIMATE SCALE MARKING 0.62ML AND THERE ARE SIGNS OF DISTORTION AT THE TOP STOPPER EDGE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE 1ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE QUALITY TEAM THERE HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H10.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL: YES D.10. RETURNED TO MANUFACTURER ON: 20-JUL-2022 H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE PLUNGER IS WITHDRAWN TO THE APPROXIMATE SCALE MARKING 0.62ML AND THERE ARE SIGNS OF DISTORTION AT THE TOP STOPPER EDGE. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND THE TOP EDGE OF THE STOPPER IS OBSERVED TO BE DISTORTED DOWNWARDS INSIDE THE SYRINGE BARREL. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE 1ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE QUALITY TEAM THERE HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT THE STOPPER WAS FOUND MISALIGNED ON THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER INCIDENT OCCUR : BEFORE USE".
IT WAS REPORTED THAT THE STOPPER WAS FOUND MISALIGNED ON THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER INCIDENT OCCUR : BEFORE USE."
IT WAS REPORTED THAT THE STOPPER WAS FOUND MISALIGNED ON THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE PLUNGER BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER INCIDENT OCCUR : BEFORE USE"
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693280 | BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON MEDICAL (SINGAPORE) | 305780 | 1237349 | 30382903057802 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |