MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381167
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2019
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 angiocath¿ iv catheter was deformed.This was discovered after use.The following information was provided by the initial reporter: the user complained that the tip of catheter was deformed.
Additional Manufacturer Narrative
Investigation summary: a device history review was conducted for lot number 7177761.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.Additionally, the damage observed in the returned sample, prompted our engineers to investigated the manufacturing process.By incorrectly setting up the machinery our engineers successfully recreated the deformed catheter tip; also successfully created the damage by clogging the manufacturing die, unfortunately they were unable to confirm which of the scenarios was the root cause at the conclusion of their review.To address this issue we have retrained our staff on the correct setup and monitoring of the manufacturing line.Conclusion: based on investigation developed, the reported defect was confirmed.Engineering team reviewed the rf process with the intention of finding some evidence that could show the source from the reported defect however nothing extraordinary was noticed.The team could reproduce the defect of 2 ways (clogged die or incorrect setup).
Event or Problem Description
It was reported that bd angiocath¿ iv catheter was deformed.This was discovered after use.The following information was provided by the initial reporter: the user complained that the tip of catheter was deformed.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• 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: 8895756
• Report Number: 9610847-2019-00509
• Device Sequence Number: 14090377
• Product Code: FOZ
• UDI-Device Identifier: 30382903811671
• UDI-Public: 30382903811671
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K151698
• 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): 09/24/2019

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: 06/30/2022
• Device Catalogue Number: 381167
• Device Lot Number: 7177761
• Initial Date Received by Manufacturer: 07/29/2019
• Supplement Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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