MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA 3-WAY STOPCOCK

Catalog Number 394602

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2020

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.(b)(4).

Event Description

It was reported that the bd connecta¿ 3-way stopcock was deformed and stuck in the needle, and broke when twisted out.The following information was provided by the initial reporter, translated from (b)(6) to english: "the connecta was stuck in the indwelling needle, and the connecta was deformed if it was twisted slightly harder, and the connector was very soft.After the indwelling needle is pulled out, twist the connecta to break in the indwelling needle.".

Event Description

It was reported that the bd connecta¿ 3-way stopcock was deformed and stuck in the needle, and broke when twisted out.The following information was provided by the initial reporter, translated from chinese to english: "the connecta was stuck in the indwelling needle, and the connecta was deformed if it was twisted slightly harder, and the connector was very soft.After the indwelling needle is pulled out, twist the connecta to break in the indwelling needle.".

Manufacturer Narrative

H6: investigation summary a device history record review was completed by our quality engineer team for provided lot number 8278821.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.It is recommended that the instructions for use are closely followed when handling the connecta product.The user should ensure that the match and fit are correct to avoid damage to the connector.Further action has not been determined necessary at this time.

• Brand Name: BD CONNECTA 3-WAY 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: 10909971
• MDR Text Key: 226066286
• Report Number: 9610847-2020-00380
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 394602
• Device Lot Number: 8278821
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1