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

Catalog Number 394995

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer 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.

Event Description

It was reported that bd connecta¿ stopcock catheter broke.This was discovered during use.The following information was provided by the initial reporter: according to our telephone interview this morning, i confirm that we will be returning 149 defective 3v valves.Indeed, according to hospital users, several parts of this batch are split and opened when connected.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9186091 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this incident, the thirty-six unused samples provided by the customer were evaluated by our quality team.Each of the provided samples was functionally tested and all of the samples were found to perform properly within specification.As the provided samples did not display the reported defect, an exact cause for the reported incident could not be determined.H3 other text : see h.10.

Event Description

It was reported that bd connecta¿ stopcock catheter broke.This was discovered during use.The following information was provided by the initial reporter: according to our telephone interview this morning, i confirm that we will be returning 149 defective 3v valves.Indeed, according to hospital users, several parts of this batch are split and opened when connected.

• 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
• MDR Report Key: 9473705
• MDR Text Key: 192059019
• Report Number: 9610847-2019-00742
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 394995
• Device Lot Number: 9186091
• Initial Date Manufacturer Received: 11/29/2019
• Initial Date FDA Received: 12/16/2019
• Supplement Dates Manufacturer Received: 11/29/2019
• Supplement Dates FDA Received: 02/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other