BD ® QUINCKE NEEDLE
Report
- Report Number
- 3003152976-2023-00259
- Event Type
- Injury
- Date Received
- June 28, 2023
- Date of Event
- May 21, 2023
- Report Date
- August 21, 2023
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- PMA / PMN Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVALUTION?: YES D.9. RETURNED TO MANUFACTURER ON: 12-JUL-2023 H.6. INVESTIGATION SUMMARY: BOTH PHOTOS AND THE PHYSICAL SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE NEEDLE IS OBSERVED TO BE BROKEN IN HALF. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111013 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON ANY OF THE NEEDLES. PRODUCT UNDERGOES VISUAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE, VERIFYING THERE ARE NO DEFECTS OR DAMAGE ON THE PRODUCT. LOT RELEASE TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. THE DETAILS INITIALLY PROVIDED WHEN REPORTING THIS INCIDENT INDICATE THE NEEDLE BROKE WHILE REMOVING THE NEEDLE FROM THE PATIENT WHO SPONTANEOUSLY MOVED. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE BD ® QUINCKE NEEDLE BROKE DURING USE AND THE NEEDLE WAS LEFT IN THE PATIENT'S BODY. SURGERY WAS PERFORMED TO REMOVE THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE SPINAL NEEDLE WAS REMOVED, THE NEEDLE WAS BROKEN AND 1/2 OF NEEDLES WAS LEFT IN THE PATIENT'S BODY. THE NEEDLE LEFT IN THE PATIENT'S BODY WAS REMOVED THROUGH THE SURGERY. THE DOCTOR AND HOSPITAL WOULD LIKE TO INVESTIGATE THE ROOT CAUSES OF THE NEEDLE BREAKAGE. IT CONCERNS BOTH THE DOCTOR AND THE PATIENT. WHEN THE NEEDLE WAS BROKEN, THE DOCTOR TOOK X-RAY TO IDENTIFY THE LOCATION OF THE NEEDLE AND USED CUT-DOWN APPROACH FOR REMOVING THE NEEDLE FROM THE PATIENT. IT WILL TAKE TIME FOR BOTH PHYSICIANS AND PATIENTS TO EVALUATE THE IMPACT..
IT WAS REPORTED THAT THE BD ® QUINCKE NEEDLE BROKE DURING USE AND THE NEEDLE WAS LEFT IN THE PATIENT'S BODY. SURGERY WAS PERFORMED TO REMOVE THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE SPINAL NEEDLE WAS REMOVED, THE NEEDLE WAS BROKEN AND 1/2 OF NEEDLES WAS LEFT IN THE PATIENT'S BODY. THE NEEDLE LEFT IN THE PATIENT'S BODY WAS REMOVED THROUGH THE SURGERY. THE DOCTOR AND HOSPITAL WOULD LIKE TO INVESTIGATE THE ROOT CAUSES OF THE NEEDLE BREAKAGE. IT CONCERNS BOTH THE DOCTOR AND THE PATIENT. WHEN THE NEEDLE WAS BROKEN, THE DOCTOR TOOK X-RAY TO IDENTIFY THE LOCATION OF THE NEEDLE AND USED CUT-DOWN APPROACH FOR REMOVING THE NEEDLE FROM THE PATIENT. IT WILL TAKE TIME FOR BOTH PHYSICIANS AND PATIENTS TO EVALUATE THE IMPACT..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1677852 | BD ® QUINCKE NEEDLE | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON, S.A. | 2111013 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |