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

Catalog Number 394602

Device Problem Packaging Problem (3007)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 while using bd connecta¿ stopcock the packaging wasn't sealed properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: when the infusion tee is used, it is found that the package of the tee is cracked and not sealed.Immediately discard it and replace it with a well-sealed tee.

Event Description

It was reported while using bd connecta¿ stopcock the packaging wasn't sealed properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: when the infusion tee is used, it is found that the package of the tee is cracked and not sealed.Immediately discard it and replace it with a well-sealed tee.

Manufacturer Narrative

H.6.Investigation summary: it was reported the package of the tee is cracked and not sealed.As a sample was not returned, a thorough sample investigation could not be completed.For a better investigation, photos or samples should be provided.A device history record review was completed for provided material number 394602, lot 2151109.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.There were no nonconformance(s), capas or abnormal conditions noted at the time of production.At the time of the dhr review, there were no changes to the process and/or equipment that would have affected the manufacturing of the device.Based on the investigation, bd was not able to confirm the failure mode indicated by the customer.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD CONNECTA¿ STOPCOCK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17807368
• MDR Text Key: 324133800
• Report Number: 9610847-2023-00264
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903946020
• UDI-Public: (01)00382903946020
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394602
• Device Lot Number: 2151109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2022
• 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