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

Catalog Number 394995

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/13/2022

Event Type  malfunction  

Event Description

It was reported that bd connecta¿ stopcock had a loose connection.The following information was provided by the initial reporter: " the plug at the tap is not screwed on, which means that liquid leaks out - such as.Chemicals - it does not work!".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.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 had a loose connection.The following information was provided by the initial reporter: " the plug at the tap is not screwed on, which means that liquid leaks out - such as.Chemicals - it does not work!".

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 2/21/2022.H6: investigation: our quality engineer inspected the 10 samples submitted for evaluation.The reported issue was not confirmed upon inspection and testing of the samples.No abnormalities or damages were observed on the returned samples.The samples were also functionally tested following bd¿s own internal leakage testing guidelines and none of the samples showed any signs of leakage.Bd cannot determine a manufacturing root cause since the reported defect was not confirmed.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that bd connecta¿ stopcock had a loose connection.The following information was provided by the initial reporter: "the plug at the tap is not screwed on, which means that liquid leaks out - such as.Chemicals - it does not work!".

• 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: 13416163
• MDR Text Key: 285769652
• Report Number: 9610847-2022-00035
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394995
• Device Lot Number: 1239991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2021
• 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