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

Catalog Number 394600

Device Problem Break (1069)

Patient Problem Hypoglycemia (1912)

Event Date 12/14/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd connecta¿ stopcock was damaged, but still operable and leaked.The following information was provided by the initial reporter: "the tap connected to the infusion line of npt was found broken".

Event Description

It was reported that bd connecta¿ stopcock was damaged, but still operable and leaked.The following information was provided by the initial reporter: "the tap connected to the infusion line of npt was found broken".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 1/18/2022.H6: investigation: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue was confirmed upon inspection of the sample.The sample was analyzed to see if it was manufactured to specifications and the sample was found to be within spec.During manufacturing there is an automated process that can identify the presence of the reported failure mode, resulting in the halting of incorrectly manufactured product.Since the product was found within spec and there are effective detection systems for the reported failure it is unlikely for the root cause to be related to our manufacturing process.There is a possibility that the cause of the failure could be related to misuse of the device.It is recommended that prior to the use of bd products to review the instructions for use documentation supplied to ensure the greatest chances of there being no failures during use.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13239763
• MDR Text Key: 285767453
• Report Number: 9610847-2021-00652
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

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: 05/31/2024
• Device Catalogue Number: 394600
• Device Lot Number: 1154536A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/17/2021
• Initial Date FDA Received: 01/12/2022
• Supplement Dates Manufacturer Received: 02/01/2022
• Supplement Dates FDA Received: 02/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1