MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCKS CONNECTA PLUS WHITE BLEND

Catalog Number 394945

Device Problems Fluid/Blood Leak (1250); Aspiration Issue (2883)

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

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

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 during use, a bd connecta¿ stopcock malfunctioned as it was reported leaking and difficult to aspirate.There was no report of injury or medical intervention reported.

Manufacturer Narrative

Results: three sealed units were received for evaluation.Our quality engineer visually inspected the returned units and no damage was identified.Each unit was leak tested and no occlusions or leaks were observed.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Based on dhr review for lot reported of catalog 394945, all samples taken for visual and functional characteristics properly met the acceptance criteria.Quality records have been consulted for tracking and trending purposes and no issues are detected which means pretty low occurrence.Conclusion: based on investigation results to date, root cause for manufacturing process cannot be determined.

• Brand Name: BD CONNECTA¿ STOPCOCKS CONNECTA PLUS WHITE BLEND
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7117128
• MDR Text Key: 95069531
• Report Number: 9610847-2017-00185
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 394945
• Device Lot Number: 7184527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other