INSYTE AUTOG BC WING PNK 20GA X 1.0IN
Report
- Report Number
- 1710034-2024-01470
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- November 22, 2024
- Report Date
- December 11, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903826339
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.
FOLLOWING THE SUBMISSION OF THE INITIAL MDR, IT WAS DETERMINED THAT THIS MDR IS A DUPLICATE TO (B)(4) AND WILL BE VOID.
MATERIAL #:382633 BATCH#:4222721 IT WAS REPORTED BY CUSTOMER THAT BD GAUGE IV CATHETERS NOT AUTO RETRACTING PROPERLY. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. SAMPLES WERE RECEIVED IN SANDY ON 11/22/2024 FOR LOT # 4222721/382536 262 (B)(4) UNKNOWN RIGHT NOW, LET ME KNOW IF THIS IS THE WAY TO PROCEED WITH THESE SAMPLES. WITH THIS PR, ADDITIONAL REPRESENTATIVE SAMPLES WERE RECEIVED FOR THE FOLLOWING LOTS. PLEASE LET ME KNOW HOW TO PROCEED. TRK # (B)(4). (B)(4) UNITS 1309139/382633 (B)(4) UNITS 2227036/382633 (B)(4) UNITS 9290517/382633 (B)(4) 4123610/382633 (B)(4) 4267886/382633 (B)(4) 4249026/382633 (B)(4) 4102957/ 382633 (B)(4) 4234660/382533.
DUPLICATE TO (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2493986 | INSYTE AUTOG BC WING PNK 20GA X 1.0IN | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON DICKINSON | 4222721 | 00382903826339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |