MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK LEAKED

Catalog Number 394945

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/22/2018

Event Type  malfunction  

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 Description

It was reported before use of the bd connecta¿ stopcock had foreign matter.No serious injury or medical intervention was reported.

Manufacturer Narrative

A device history review was conducted for lot number 8117623.Our records show the reported lot was manufactured on 05/03/2018, and determined that this is the only instance of foreign matter being observed 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 of packaged goods.Although a photo was submitted by your facility, the image proved to be insufficient for our purposes.Process (b)(4) and process (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Based on investigation results to date, root cause for manufacturing process cannot be determined.

Event Description

It was reported before use of the bd connecta stopcock had foreign matter.No serious injury or medical intervention was reported.

• Brand Name: BD CONNECTA¿ STOPCOCK LEAKED
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8086088
• MDR Text Key: 127864780
• Report Number: 9610847-2018-00388
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8117623
• Date Manufacturer Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other