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 Defective Device (2588)

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

Event Date 08/24/2022

Event Type  malfunction  

Event Description

It was reported while using bd connecta plus3 white pegs the component was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: when i infused the patient, the venous return was through the closed valve.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for evalution?: yes.D.9.Returned to manufacturer on: 14-sep-2022 h.6.Investigation summary: our quality engineer inspected the 11 samples submitted for evaluation.The reported issue of leakage was not confirmed upon inspection and testing of the samples.Analysis of the samples showed that all 11 samples were found to be within proper manufacturing specifications.Functional testing was performed, and no issues were found with the samples.Bd cannot determine the cause of the failure since the defect was not confirmed.Production records were reviewed, and this batch was in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd connecta plus3 white pegs the component was damaged there was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: when i infused the patient, the venous return was through the closed valve.

• 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: 15450153
• MDR Text Key: 305683939
• Report Number: 9610847-2022-00352
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394601
• Device Lot Number: 2032606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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