BD INSYTE AUTOG BC WING
Report
- Report Number
- 1710034-2024-01308
- Event Type
- Malfunction
- Date Received
- November 11, 2024
- Date of Event
- October 24, 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
- OK, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTO OF TWO 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721. THE PHOTO DOES NOT DISPLAY ANY UNIT. THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE AS IT ONLY DISPLAYED THE TOP WEB LABEL. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE ACTUAL PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THESE BATCHES.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED ONE PHOTO WHICH DISPLAYED THE TOP WEB LABEL OF A 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNIT FROM LOT NUMBER 4222721. THE PHOTO DOES NOT DISPLAY ANY UNIT. THE PHOTOGRAPH PROVIDED FOR THIS INCIDENT DID NOT PRESENT SUFFICIENT EVIDENCE TO IDENTIFY OR CONFIRM THE ALLEGED FAILURE OR TO ESTABLISH A DEFINITE ROOT CAUSE AS IT ONLY DISPLAYED THE TOP WEB LABEL. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND WAS IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
ADDITIONAL INFORMATION OF FA#.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I'M REACHING OUT TO REPORT A MALFUNCTION WITH A DEVICE WE HAVE AT OUR FACILITY. IT IS THE BD INSYTE AUTO GUARD 20 G X 1.00 IN. THE NEEDLE IS SLOW TO RETRACT OR WILL NOT RETRACT COMPLETELY LEAVING THE NEEDLE EXPOSED FOR A POTENTIAL NEEDLESTICK. I WILL ATTACH THE PICTURE THAT HAS THE IDENTIFIERS ON IT. THEY HAVE SEEMED TO BE CONTAINED TO THE SAME LOT RIGHT NOW. NO IMPACT TO PATIENT. NO SERIOUS INJURY TO HCP. 10/22/2024-10/24/2024. NO SAMPLES, JUST THE LOT NUMBER THAT WAS INVOLVED THAT I SENT IN THE INITIAL INFORMATION. NO MEDICATIONS GIVEN IN THE START OF THE IV. YES, BUTTON WAS DEPRESSED. THE BUTTON APPEARED TO GET STUCK AND LEAVE A PORTION OF THE NEEDLE EXPOSED. THE NEEDLE DID RETRACT, NOT FULLY. NO NEEDLE STICK INJURIES REPORTED. YES, BUTTON WAS DEPRESSED. THE BUTTON APPEARED TO GET STUCK AND LEAVE A PORTION OF THE NEEDLE EXPOSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2213455 | 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 |