BD INSYTE AUTOG BC WING
Report
- Report Number
- 1710034-2024-01318
- Event Type
- Malfunction
- Date Received
- November 12, 2024
- Date of Event
- October 23, 2024
- Report Date
- June 16, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826339
- PMA / PMN Number
- K201075
- Removal / Correction Number
- MDS-25-5274
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- 003
Narratives
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.
ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE CUSTOMER DID NOT USE THE DEVICE PER THE INSTRUCTIONS FOR USE LEADING TO A TIP ADHESION (NEEDLE STUCK TO CATHETER) WHICH IS NOT MDR REPORTABLE. CORRECTION: CANCEL MDR.
INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382633 AND LOT NUMBER 4241245 & 4222721. 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. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
ADDITIONAL INFORMATION OF FA#.
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PLACING 20G PIV LOT 4222721 AND NEEDLE NOT RETRACTING EFFECTIVELY: GETTING STUCK IN CANNULA. NOTICED THIS WITH A PT PRIOR TO THAT 20G PIV WAS DIFFICULT TO ADVANCE AND NEEDLE WAS SLOW TO RETRACT. FOR THIS PT THE CANNULA WAS ADVANCED AND WHEN THE NEEDLE WAS RETRACTED THE ENTIRE NEEDLE AND CANNULA CAME OUT LEAVING A LARGE BRUISE. WE TESTED ANOTHER 20G OF THIS LOT AND THE NEEDLE WAS STUCK IN THE CANNULA AS THOUGH THE NEEDLE IS TOO LARGE FOR THE CANNULA. THIS PRODUCT CONTINUES TO NOT RETRACT PROPERLY, OFTEN REQUIRING PULLING OUT THE ENTIRE NEEDLE FROM THE CATHETER AFTER IV IS PLACED AND REPEATEDLY PUSHING THE RETRACT BUTTON UNTIL THE NEEDLE RETRACTS AND THE "SHARP" CAN BE PLACED IN THE SHARP BIN. CUSTOMER RESPONSE RECEIVED ON 29-OCT-2024: NO INJURES OR HARM REPORTED OTHER THAN THE BRUISING ON PATIENT. THE ISSUES EXPERIENCED WERE STATING THAT THE NEEDLE WAS NOT RETRACTING EFFECTIVELY: GETTING STUCK IN CANNULA. TESTED ANOTHER 20G OF THIS SAME LOT AND NEEDLE WAS STUCK IN CANNULA. CONTINUES TO NOT RETRACT PROPERLY, OFTEN REQUIRING PULLING OUT THE ENTIRE NEEDLE FROM THE CATHETER AFTER IV IS PLACED AND REPEATEDLY PUSHING THE RETRACT BUTTON UNTIL THE NEEDLE RETRACTS AND THE SHARP CAN BE PLACED IN SHARP BIN. CUSTOMER RESPONSE RECEIVED ON 01-NOV-2024: UPDATE FOR QUESTIONS: LOOKS LIKE THE LOT 4222721 OCCURRED ON (B)(6) AND THAT WAS MULTIPLE ON THAT DAY. HOPE THIS HELPS WITH ANNOTATING. JUST WANT TO MAKE SURE WE COMMUNICATE THIS IN CASE YOU WERE ALREADY RECEIVING THESE ISSUES FROM OTHER HOSPITALS, AND OR CLINICS.
CUSTOMER RESPONSE RECEIVED ON (B)(4)2024. I RECEIVED AN EMAIL BACK FROM ONE OF THE DEPTS. THEY MENTIONED THAT THEY DID NOT DO THE 360 DEGREE ROTATION ¿ AND THEY ARE NOW AWARE TO BREAK THE SEAL.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1513561 | BD INSYTE AUTOG BC WING | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4222721 | 00382903826339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |