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

Catalog Number 394995

Device Problem Material Rupture (1546)

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

Event Date 12/13/2021

Event Type  malfunction  

Event Description

It was reported that 6 bd connecta¿ stopcock experienced ruptured tubing.The following information was provided by the initial reporter: the technician has complained that, on several occasions (5 or 6 units), when inserting the contrast material, the extension cord has burst.They are using them with a pressure injector at flow 3, as usual, and have never had a problem until recently.

Manufacturer Narrative

Initial reporter phone #: an additional phone # was provided as (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 that 6 bd connecta¿ stopcock experienced ruptured tubing.The following information was provided by the initial reporter: the technician has complained that, on several occasions (5 or 6 units), when inserting the contrast material, the extension cord has burst.They are using them with a pressure injector at flow 3, as usual, and have never had a problem until recently.

Manufacturer Narrative

Initial reporter phone #: an additional phone # was provided as (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary : since no photos or samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported that 6 bd connecta¿ stopcock experienced ruptured tubing.The following information was provided by the initial reporter: the technician has complained that, on several occasions (5 or 6 units), when inserting the contrast material, the extension cord has burst.They are using them with a pressure injector at flow 3, as usual, and have never had a problem until recently.

• Brand Name: BD CONNECTA¿ 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: 13226330
• MDR Text Key: 285767197
• Report Number: 9610847-2021-00649
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 394995
• Device Lot Number: 1062039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2021
• 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