BD LUER-LOK¿ TIP 3ML SYRINGE
Report
- Report Number
- 2243072-2021-02728
- Event Type
- Malfunction
- Date Received
- November 16, 2021
- Date of Event
- October 19, 2021
- Report Date
- April 10, 2022
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMF
- UDI-DI
- 30382903096573
- PMA / PMN Number
- SEE H10
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 26-OCT-2021. H.6. INVESTIGATION: FIVE SAMPLES FROM LOT 1131287, THREE SAMPLES FROM LOT 1131303 , SIX SAMPLES FROM LOT 1131289, AND TWO PIECES OF CONNECTORS WHICH ARE NOT BD PRODUCTS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION, NO DEFECTS OR DAMAGE OBSERVED. LEAKAGE TEST PERFORMED, NO DEFECTS WERE OBSERVED. ALL TESTING WAS REVIEWED FOR THE POTENTIAL LOT NUMBERS, INCLUDING LEAKAGE, AND INSPECTION RESULTS WITH NO ISSUES IDENTIFIED RELATED TO THE REPORTED MALFUNCTION. A DEVICE HISTORY REVIEW WAS PERFORMED AND FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF LOT 1131303, 1131289, 1131287, ALL PRODUCT WAS MANUFACTURED ACCORDING TO SPECIFICATION. BASED ON OUR INVESTIGATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE MANUFACTURING LOCATIONS FOR THIS PRODUCT THE POSSIBLE 510K NUMBERS ARE REPORTED BELOW: PMA / 510(K)#: K980987 ((B)(4)) . PMA / 510(K)#: K151766 ((B)(4)). 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 LUER-LOK¿ TIP 3ML SYRINGE WAS LEAKING AT THE CONNECTION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED "THESE LOT NUMBERS ARE NOT ALL TESTED THESE ARE JUST WHAT WE HAVE IN STOCK, BUT WHAT IS HAPPENING IS WHEN IT IS CONNECTED TO THE IV MICRO TUBING IT IS LEAKING, SO IT IS NOT SEALING AND LEAKING ALL OVER THE FLOOR. THE OLDER ONES DO NOT GIVE ANY PROBLEMS BUT THE ONES WITH THIS NEWER BD LOGO LEAK. NO PATIENT HARM REPORTED. BUT THERE WAS AN ISSUE WITH BLEED BACK."
IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP 3ML SYRINGE WAS LEAKING AT THE CONNECTION. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED "THESE LOT NUMBERS ARE NOT ALL TESTED THESE ARE JUST WHAT WE HAVE IN STOCK, BUT WHAT IS HAPPENING IS WHEN IT IS CONNECTED TO THE IV MICRO TUBING IT IS LEAKING, SO IT IS NOT SEALING AND LEAKING ALL OVER THE FLOOR. THE OLDER ONES DO NOT GIVE ANY PROBLEMS BUT THE ONES WITH THIS NEWER BD LOGO LEAK. NO PATIENT HARM REPORTED. BUT THERE WAS AN ISSUE WITH BLEED BACK."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1719477 | BD LUER-LOK¿ TIP 3ML SYRINGE | PISTON SYRINGE | FMF | BECTON DICKINSON | 309657 | UNKNOWN | 30382903096573 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |