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

Catalog Number 394945

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

(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 the extension line connected to the bd connecta¿ stopcock was found bent before use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the extension line (connected to the stopcock), has founded bended in several units.".

Manufacturer Narrative

Investigation: a device history report was conducted for lot number 8281715.During our review no abnormalities related to this event were found during our monitoring of the manufacturing process.This lot of pegasus was manufactured on 9/25/2017-9/26/2017, and this is the only instance of kinked tubing occurring in this lot.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Based on the dimension of the deformity in the tubing of the device submitted for evaluation, bd investigators were able to determine that the root cause for this complaint is operator error while operating machinery involved in the packaging process.Based on investigation results to date, probable root cause of tubing kinked was associated to incorrect alignment on head of insertion and a detached of jaw of gripper.

Event Description

It was reported that the extension line connected to the bd connecta¿ stopcock was found bent before use.The following information was provided by the initial reporter, translated from spanish to english: "the extension line (connected to the stopcock), has founded bended in several units.".

• 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: 8544775
• MDR Text Key: 145945698
• Report Number: 9610847-2019-00325
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/17/2019

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
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 394945
• Device Lot Number: 8281715
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other