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

Catalog Number 394605

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/27/2018

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8110572, medical device expiration date: 2021-03-31, device manufacture date: 2018-06-06.Medical device lot #: 8037902 , medical device expiration date: 2021-01-31, device manufacture date: 2018-03-13.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 "dirt" on the bd connecta¿ stopcock cap.

Event Description

The customer claimed that there was dirt on the on the bd connecta¿ stopcock cap where needle injected.The affected quantity was 1500pcs, in which 1123pcs were returned to the distributor.

Manufacturer Narrative

Correction: b.5.Describe event or problem: the customer claimed that there was dirt on the on the bd connecta¿ stopcock cap where needle injected.The affected quantity was 1500pcs, in which 1123pcs were returned to the distributor.Investigation summary: in response to the event reported by the facility a device history review was conducted for lot numbers 8037902 & 8110572.Our records determined that this is the only instance of foreign material being reported in either lot.According to the sampling plan applied for product performance, both lost were accepted and released without defects being noted during the final assembly or visual inspections.Investigation conclusion: a sample could not be obtained for evaluation and testing by the manufacturer.Bd was not able to duplicate or confirm the customer¿s indicated failure mode.Root cause description: without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Rationale: bd will continue to monitor this issue and in case any emerging trend is detected, further actions will be taken if necessary.

• 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: 8206868
• MDR Text Key: 131767110
• Report Number: 9610847-2018-00446
• 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: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394605
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other