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

Catalog Number 394945

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)

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

Event Date 11/01/2019

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 the tubing is kinked and fluid not flowing at normal rate with a bd connecta¿ stopcock.The following information was provided by the initial reporter: connecta placed in the package so it gets kinked in the package, this kinked position is so tight, patients don¿t necessarily get the drugs they should get.Concern the place where tube has been kinked, is so tight drug/fluid is not flowing in normal rate.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot numbers 9172654 and 9088611.The review did not reveal any detected quality issues during the production process for either lot number that could have contributed to this reported incident.To further investigate this issue, picture samples and two physical samples were received for evaluation by our quality engineer team.Through examination of the samples, one of the samples displayed kinked tubing.This defective sample was then functionally tested and no signs of leakage or occlusion were observed.There are current quality controls in place to detect kinked tubing during the production process.Based on the investigation results, an exact cause for this incident could not be determined.

Event Description

It was reported that during use the tubing is kinked and fluid not flowing at normal rate with a bd connecta¿ stopcock.The following information was provided by the initial reporter: connecta placed in the package so it gets kinked in the package, this kinked position is so tight, patients don¿t necessarily get the drugs they should get.Concern the place where tube has been kinked, is so tight drug/fluid is not flowing in normal rate.

• 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 ; MX
• MDR Report Key: 9547985
• MDR Text Key: 195274532
• Report Number: 9610847-2019-00801
• 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: 02/10/2020

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: 05/31/2022
• Device Catalogue Number: 394945
• Device Lot Number: 9172654
• Initial Date Manufacturer Received: 12/09/2019
• Initial Date FDA Received: 01/03/2020
• Supplement Dates Manufacturer Received: 12/09/2019
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other