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

Catalog Number	381157
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• 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
• MDR Report Key: 7974131
• Report Number: 9610847-2018-00331
• Device Sequence Number: 1578845
• Product Code: FOZ
• UDI-Device Identifier: 30382903811572
• UDI-Public: 30382903811572
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/12/2018

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: 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
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 11/13/2018
• 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