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

Catalog Number 394605

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/03/2023

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 outer packaging of the bd connecta¿ stopcock had the lot labeled as 2091994, while the inner label listed it as 2091994b.This occurred with 5000 products.The following information was provided by the initial reporter, translated from chinese: "at the distributor, when entering the platform, it was found that the batch number of the product package was inconsistent with the batch number of the internal product.Outer packaging batch number: 2091994; internal product batch number: 2091994b.".

Event Description

It was reported that the outer packaging of the bd connecta¿ stopcock had the lot labeled as 2091994, while the inner label listed it as 2091994b.This occurred with 5000 products.The following information was provided by the initial reporter, translated from chinese: "at the distributor, when entering the platform, it was found that the batch number of the product package was inconsistent with the batch number of the internal product.Outer packaging batch number: 2091994; internal product batch number: 2091994b.".

Manufacturer Narrative

H6.Investigation summary: bd was not able to confirm the customer¿s indicated failure mode because samples or pictures were not provided to perform better investigation.A device history record review as completed for provided material number 394605, lot 2091994.The product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s) or abnormal conditions noted at the time of production.This condition is normal in the nogales manufacturing process since a letter is placed at the end of the batch of the unit package which indicates the shift in which the batch of product is manufactured.This is by requirement of our packaging procedure pg-172sp which mentions that the product must contain this letter.

• 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: 16219770
• MDR Text Key: 308780628
• Report Number: 9610847-2023-00006
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394605
• Device Lot Number: 2091994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• 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