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

Catalog Number 381157

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported with the use of the bd angiocath¿ iv catheter there was an issue with foreign matter.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 7209534.Our records show it was manufactured on august 31, 2017, and determined that this is the third instance of foreign matter being identified in this 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 of packaged goods.Visual evaluation of the submitted samples and the resulting review of the manufacturing process determined that the identity of the material is solidified silicone.Silicone is a material used to manufacture this device, and is applied to the catheter as a lubricant for reduced resistance during insertion.Excess application of the lubricant is currently possible due to limitations in the manufacturing process.Bd is currently investigating potential process changes to eliminate the occurrence of similar events.Based on investigation results to date, root cause was associated to our current process to apply silicon to the catheter (dipping process).Capa process required to mitigate the reported failure mode (450094).

Event Description

It was reported with the use of the bd angiocath¿ iv catheter there was an issue with foreign matter.There was no report of injury or medical intervention.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7974131
• MDR Text Key: 124130375
• Report Number: 9610847-2018-00331
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903811572
• UDI-Public: 30382903811572
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 381157
• Device Lot Number: 7209534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Date Manufacturer Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other