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

Catalog Number 394945

Device Problem Infusion or Flow Problem (2964)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the tube is kinked prior to use with a bd connecta¿ stopcock.The following information was provided by the initial reporter: issue with the connecta stopcock with extension set; the tube is so bent that it cannot be straightened and therefore cannot be used.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9220680.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To further investigate this issue, seven physical samples were provided for evaluation by our quality engineer team.Through examination, six of the seven samples displayed kinked tubing, however, no further signs of tubing damage or cracking were observed.At this point in time, a definite cause related to the manufacturing process cannot be determined for this issue.

Event Description

It was reported that the tube is kinked prior to use with a bd connecta¿ stopcock.The following information was provided by the initial reporter: issue with the connecta stopcock with extension set; the tube is so bent that it cannot be straightened and therefore cannot be used.

• 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: 9764121
• MDR Text Key: 195300878
• Report Number: 9610847-2020-00063
• 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: 03/23/2020

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: 07/31/2022
• Device Catalogue Number: 394945
• Device Lot Number: 9220680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/27/2020
• Supplement Dates Manufacturer Received: 02/07/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other