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

Catalog Number 394600

Device Problem Material Deformation (2976)

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

Event Date 03/10/2023

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 the luer lock cap on the bd connecta¿ stopcock was deformed and made it difficult to connect the catheter.This occurred with 2 stopcocks.The following information was provided by the initial reporter: "they said when connecting the catheter, it is hard to it.Reviewed the evidence provided and found that luer lock cap is deformed and leaning to one side make it difficult to connect the catherer.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 23-may-2023.Investigation summary: our quality engineer inspected the 2 photos and one sample submitted for evaluation.The reported issue of molding defective ¿ other was confirmed upon inspection of the samples.Analysis of the sample showed that the luer lock was assembled incorrectly, resulting in the inability for the collar to rotate.Bd determined that the cause of the failure was related to our assembly process.Actions are being taken to improve our preventative systems to ensure the observed failure mode does not occur again.Production records were reviewed, and this batch met our manufacturing product specification requirements.

Event Description

It was reported that the luer lock cap on the bd connecta¿ stopcock was deformed and made it difficult to connect the catheter.This occurred with 2 stopcocks.The following information was provided by the initial reporter: "they said when connecting the catheter, it is hard to it.Reviewed the evidence provided and found that luer lock cap is deformed and leaning to one side make it difficult to connect the catheter.".

• 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 ; 8448235433
• MDR Report Key: 16657327
• MDR Text Key: 313013632
• Report Number: 9610847-2023-00077
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 06/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394600
• Device Lot Number: 2182345
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2022
• 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