MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381544
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub during use and was "bent/smashed".The following information was provided by the initial reporter: "customer called to report that a couple of nurses have brought catheters to her stating that they don't advance and the catheters are either broken at the tip or bent/smashed.She was unable to provide dates or patient identifiers, she stated it has happened a handful off times.".
Additional Manufacturer Narrative
H.6.Investigation: bd received an 18 gauge insyte autoguard winged catheter adapter assembly from lot 0023722 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed damage to the tip of the catheter tubing.A microscopic inspection was then performed on the catheter tip and a small part of the catheter material is missing from the catheter tubing resulting in a jagged tip.Tearing to the catheter tubing can also be observed on the sides of a distinctive v shape point.This v shape indicated that the needle had pierced through the catheter tubing.The tearing to the catheter and the spear through resulted in the catheter folding into itself seen above.Based off the visual inspection the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined but it didn't appear to be a manufacturing defect.H3 other text : see h.10.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ shielded iv catheter broke from the hub during use and was "bent/smashed." the following information was provided by the initial reporter: "customer called to report that a couple of nurses have brought catheters to her stating that they don't advance and the catheters are either borken at the tip or bent/smashed.She was unable to provide dates or patient identifiers, she stated it has hanppened a handful off times.".

• Brand Name: BD INSYTE AUTOGUARD SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10301878
• Report Number: 1710034-2020-00466
• Device Sequence Number: 2234411
• Product Code: FOZ
• UDI-Device Identifier: 30382903815440
• UDI-Public: 30382903815440
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 381544
• Device Catalogue Number: 381544
• Device Lot Number: 0023722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other