MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANGIOCATH SPECIAL GRAY 16GA X 5.25IN; INTRAVASCULAR CATHETER

Catalog Number	382259
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the angiocath special gray 16 ga x 5.25 in the customer complained that it broke during thoracentesis.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: the customer complaint that the catheter broken in body during extubation of the thoracentesis.
Additional Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 8114999.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Based on investigation results to date, root cause to manufacturing process cannot be determined.No samples or photos were returned for evaluation.
Event or Problem Description
It was reported that during use of the angiocath special gray 16ga x 5.25in the customer complained that it broke during thoracentesis.Foreign complaint the following information was provided by the initial reporter, translated from chinese to english: the customer complaint that the catheter broken in body during extubation of the thoracentesis.

• Brand Name: ANGIOCATH SPECIAL GRAY 16GA X 5.25IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 8911427
• Report Number: 9610847-2019-00527
• Device Sequence Number: 13889845
• Product Code: FOZ
• UDI-Device Identifier: 30382903822592
• UDI-Public: 30382903822592
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K013800
• 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): 09/18/2019

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: 04/30/2023
• Device Catalogue Number: 382259
• Device Lot Number: 8114999
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 08/01/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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