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

Catalog Number 394995

Device Problem Defective Device (2588)

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

Event Date 07/25/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (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 that there was dilation in the bd connecta¿ stopcock tubing during injection.There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

Investigation summary: photos were returned in support of this complaint.Based on photos provided the device showed damaged (balloons) on the tubing.Apparently caused by high pressure application, the way to damage the tube is omitting the ifu recommendations.Internal rejects database was consulted for damaged tubing and no issues related have been reported/detected.It is important to mention that connecta product should be used for infusion therapy only.Process fmea rm5838 and process eura (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined.

Event Description

It was reported that there was dilation in the bd connecta¿ stopcock tubing during injection.There was no report of exposure, injury, or medical intervention.

• Brand Name: BD CONNECTA¿ STOPCOCK
• 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: 7827010
• MDR Text Key: 118747327
• Report Number: 9610847-2018-00277
• 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: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 394995
• Device Lot Number: 8037787
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other