MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ PLUS STOPCOCK

Catalog Number 394900

Device Problems Leak/Splash (1354); Air/Gas in Device (4062)

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

Event Date 12/21/2022

Event Type  malfunction  

Event Description

It was reported that 2 bd connecta¿ plus stopcocks had air in the line and leaked fluid from between the connector and extension tubing during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported about leakage of the fluid and air coming from the connection between the connector (cat#: 394900) and top corporation's ext.Tubing.Another product was used to complete the administration.".

Manufacturer Narrative

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 that 2 bd connecta¿ plus stopcocks had air in the line and leaked fluid from between the connector and extension tubing during use.The following information was provided by the initial reporter, translated from japanese: "the customer reported about leakage of the fluid and air coming from the connection between the connector (cat #: 394900) and top corporation's ext.Tubing.Another product was used to complete the administration.".

Manufacturer Narrative

H6.Investigation summary: our quality engineer inspected the 1 sample submitted for evaluation.The reported issues of leakage and air bubbles / air in line were not confirmed upon inspection and testing of the samples.Analysis of the sample showed that there were no abnormalities or defects on the returned sample.The returned sample underwent our internal leakage testing, and the sample showed no signs of leakage.Since the failure modes were not confirmed during sample evaluation a manufacturing related root cause could not be determined.Production records were reviewed, and this batch met our manufacturing product specification requirements.

• Brand Name: BD CONNECTA¿ PLUS STOPCOCK
• Type of Device: STOPCOCK
• 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: 16200163
• MDR Text Key: 309044036
• Report Number: 9610847-2023-00001
• 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: 02/21/2023

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: 394900
• Device Lot Number: 2003250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2022
• Initial Date FDA Received: 01/18/2023
• Supplement Dates Manufacturer Received: 02/21/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2022
• 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