MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA 3-WAY STOPCOCK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 394900

Device Problem Improper Flow or Infusion (2954)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported while using bd connecta 3-way stopcock air was found in the line.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about air generation during infusion.One hour after the start of administration, air was generated in the three-way valve (stopcock).

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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 3-way stopcock air was found in the line.There was no report of patient impact.The following information was provided by the initial reporter: this is a report about air generation during infusion.One hour after the start of administration, air was generated in the three-way valve (stopcock).

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 31-may-2022.H.6.Investigation: our quality engineer inspected the 1 sample submitted for evaluation.The reported issue of air bubbles / air in line was not confirmed upon inspection and testing of the sample.During the visual inspection, no defects or abnormalities were observed on the sample.The sample underwent leakage testing to see if the sample is properly sealed and no signs of leakage were observed.Bd was unable to determine a manufacturing related root cause since the failure was not confirmed.A device history review could not be performed since the lot number was not provided for the investigation.

• Brand Name: BD CONNECTA 3-WAY 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14491341
• MDR Text Key: 292603910
• Report Number: 9610847-2022-00192
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394900
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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