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

Catalog Number 394602

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/17/2022

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.

Event Description

It was reported that 10 bd connecta¿ stopcock 3-way nut was unable to be tightened.The following information was provided by the initial reporter: when the product was in use, it is found that the connecta cannot be locked and the nut cannot be tightened.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 24-jan-2023 h6: investigation summary our quality engineer inspected the 8 samples submitted for evaluation.The reported issue of connection issues was not confirmed upon inspection of the samples.Analysis of the sample showed that there were no abnormalities, damages, or defects present on the returned samples.Bd cannot determine a manufacturing related root cause since the defect was not confirmed.Production records were reviewed, and this batch met our manufacturing product specification requirements.See h10.

Event Description

It was reported that 10 bd connecta¿ stopcock 3-way nut was unable to be tightened.The following information was provided by the initial reporter: when the product was in use, it is found that the connecta cannot be locked and the nut cannot be tightened.

• Brand Name: BD CONNECTA¿ STOPCOCK 3-WAY
• 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: 15962577
• MDR Text Key: 307934759
• Report Number: 9610847-2022-00465
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 394602
• Device Lot Number: 1061606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2021
• 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