BD INSYTE AUTOG BC WING
Report
- Report Number
- 1710034-2024-01290
- Event Type
- Malfunction
- Date Received
- November 7, 2024
- Date of Event
- October 21, 2024
- Report Date
- February 4, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826339
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE SAMPLES AND PHOTOGRAPH SUBMITTED FOR EVALUATION. BD RECEIVED 11 SEALED AND 3 UNSEALED 20GA X 1.00IN. INSYTE AUTOGUARD BC WINGED UNITS FROM LOT NUMBER 4222721. ADDITIONALLY, ONE PHOTO WAS PROVIDED, WHICH SHOWED ONE 20G WINGED IV CATHETER AND THREE UNIT PACKAGES FROM LOTS 4116716 (22G), 4222721 (20G), AND 4057790 (20G). YOUR REPORT COULD NOT BE CONFIRMED FROM THE PHOTOGRAPH. THE 11 SEALED SAMPLES WERE TESTED BY BREAKING TIP ADHESION, SLIGHTLY ADVANCING THE CATHETER, AND THEN ACTIVATING THE BUTTON. A STOPWATCH WAS ACTIVATED WHEN THE BUTTON WAS ACTIVATED AND STOPPED WHEN THE NEEDLE FULLY RETRACTED IN THE BARREL. THE FUNCTIONAL TEST SHOWED THAT THE UNUSED SAMPLES EXCEEDED THE SPECIFICATION FOR RETRACTION TIME THEREFORE CONFIRMING YOUR REPORTED ISSUE. THE CAUSE APPEARED TO BE MANUFACTURING RELATED DUE TO EXCESSIVE GEL IN THE CHAMBER. THE 3 UNSEALED PHYSICAL SAMPLES THAT WERE PROVIDED WERE ALREADY RETRACTED AND WITH NO CATHETERS PROVIDED. THE UNITS WERE PLACED BACK INTO INITIAL POSITION AND VISUALLY INSPECTED AND NO DAMAGES WERE DISCOVERED. THE UNITS RETRACTED SUCCESSFULLY. 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. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.
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 AND ONE 22GA X 1.00IN. INSYTE AUTOGUARD BC UNIT FROM LOT NUMBER 4116716. THE PHOTO DOES NOT DISPLAY ANY UNIT. ONLY THE LABELING OF THE PACKAGES IS SHOWN IN THE PHOTO. 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. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
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.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INSYTE AUTOG BC WING NEEDLE WAS SLOW TO RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PUSH BUTTON ON IAGBC IS SIGNIFICANTLY DELAYED IN RETRACTING THE NEEDLE, RISKING NEEDLE STICK TO THE NURSE. POTENTIAL NEEDLE STICK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1625606 | BD INSYTE AUTOG BC WING | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4057790 | 00382903826339 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |