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

Catalog Number 394600

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 3 bd connecta¿ stopcocks connected to the hub of the central venous catheter were cracked and leaked during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "three stopcocks were placed on a central venous catheter with three lumens, all taken from the same package.The stopcocks were connected to syringe pump infusion extensions.After a few hours they noticed a leak from the central body of the stopcock, under the white tap (it seemed cracked).The leak affected all three taps placed on the lumen hubs.The used stopcocks were discarded and are not available for analysis because they were placed on a covid patient." "the stopcocks were connected to the hub of cvc, on the hub of stopcocks two bd max zero were connected.Extensions were connected from infusion devices ( fresenius syringe pump ) to max zero.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/16/2020.H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot number 9281367.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.To aid in the investigation of this incident, forty-one unused samples were returned for evaluation by our quality engineer team.Through visual inspection no signs of damage, cracking, or any defect could be identified on the returned samples.

Event Description

It was reported that 3 bd connecta¿ stopcocks connected to the hub of the central venous catheter were cracked and leaked during use.The following information was provided by the initial reporter, translated from italian to english: "three stopcocks were placed on a central venous catheter with three lumens, all taken from the same package.The stopcocks were connected to syringe pump infusion extensions.After a few hours they noticed a leak from the central body of the stopcock, under the white tap (it seemed cracked).The leak affected all three taps placed on the lumen hubs.The used stopcocks were discarded and are not available for analysis because they were placed on a covid patient." "the stopcocks were connected to the hub of cvc, on the hub of stopcocks two bd max zero were connected.Extensions were connected from infusion devices ( fresenius syringe pump ) to max zero.".

• 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: 10989192
• MDR Text Key: 227001497
• Report Number: 9610847-2020-00408
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 394600
• Device Lot Number: 9281367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 02/09/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1