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

Catalog Number	381033
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter was burred.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the catheter was burr.
Additional Manufacturer Narrative
Investigation: our quality engineer inspected the samples and photographs submitted for evaluation.Bd received a total of (b)(4) units in which 1 unit was in an open package, all from lot number 8087872.All contents were present and intact.Through the visual/microscopic evaluation of the opened unit a white-clear particle speck was observed on the catheter tubing of the assembly.A red fiber was also observed on the tip of the cannula.The visual inspection of the (b)(4) units in sealed packages, 2 of the units also contained the white-clear particle specks.The reported issue was confirmed.The white-clear material observed near the catheter tip was confirmed to be non-foreign (plug shavings) which resulted from manufacturing during the assembly process.Since the unit that contained the red fiber was received out of its original packaging, bd could not determine a definite root cause.A device history record review showed no non-conformances associated with this issue during the production of these batches.
Event or Problem Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter was burred.No serious injury or medical intervention was reported.The following information was provided by the initial reporter: the catheter was burr.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC 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: 8537206
• Report Number: 1710034-2019-00438
• Device Sequence Number: 19440893
• Product Code: FOZ
• UDI-Device Identifier: 00382903810338
• UDI-Public: 382903810338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K110443
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 381033
• Device Lot Number: 8087872
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 04/22/2019
• Supplement Report FDA Received Date: 06/14/2019
• 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