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

Catalog Number 394601

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 11/28/2022

Event Type  malfunction  

Manufacturer Narrative

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 plus3 white pegs the product could not be detached.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the union nut of the attached extension cable cannot be detached from the product.

Manufacturer Narrative

The following fields were updated due to additional information: device available for eval yes, returned to manufacturer on: 11-jan-2023.Investigation summary our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of adapter / connector defective / damaged was not confirmed upon inspection of the sample.Analysis of the sample showed that there were no irregularities or damages on the connector.The connector was tested and there were no issues with the connection of the sample.Bd could not determine a manufacturing related root cause since the failure was not confirmed by the sample evaluation.The device history records (dhr) review was performed for the lot number material identified in this complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.

Event Description

It was reported while using bd connecta plus3 white pegs the product could not be detached.There was no report of patient impact.The following information was provided by the initial reporter, translated from german to english: the union nut of the attached extension cable cannot be detached from the product.

• Brand Name: BD CONNECTA PLUS3 WHITE PEGS
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16000527
• MDR Text Key: 307934727
• Report Number: 9610847-2022-00480
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 02/03/2023

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 Catalogue Number: 394601
• Device Lot Number: 2122346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2022
• Initial Date FDA Received: 12/16/2022
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2022
• 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