MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE PEGS; I.V. SET STOPCOCK

Catalog Number 394601

Device Problem Leak/Splash (1354)

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

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: (b)(6).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 30 connecta plus3 white pegs were damaged.The following information was provided by the initial reporter, translated from chinese: "during use, cracks were found at the product interface.".

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 2 photos submitted for evaluation.The reported issue was not confirmed upon inspection of the photos because they did not provide clear evidence of the failure.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.This is the 1st complaint for component damage - no leak for material 394601 & batch 0274749.H3 other text : see h.10.

Event Description

It was reported 30 connecta plus3 white pegs were damaged.The following information was provided by the initial reporter, translated from chinese: "during use, cracks were found at the product interface.".

• Brand Name: CONNECTA PLUS3 WHITE PEGS
• Type of Device: I.V. SET STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 12565211
• MDR Text Key: 274566034
• Report Number: 9610847-2021-00482
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 394601
• Device Lot Number: 0274749
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 10/01/2021
• Supplement Dates Manufacturer Received: 10/07/2021
• Supplement Dates FDA Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1