MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING

Catalog Number 394971

Device Problems Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 with the use of the bd connecta stopcock with valve and extension tubing there was an issue with a molding defect.The complaint picture shows a large hole in part of the tubing.There was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd connecta stopcock with valve & extension tubing there was an issue with a molding defect.The complaint picture shows a large hole in part of the tubing.There was no report of injury or further medical intervention.

Manufacturer Narrative

The device history report for lot number 7247573 was reviewed, no related abnormalities were found.Material number (b)(4) for lot 7247573 was manufactured on oct-01-2017.This is the first instance of this failure mode with this lot number.According to the sampling plan applied for product performance, this lot was accepted and released, with no defects being noted during final assembly or in packaging visual inspections.Additionally a photograph was provided for the purpose of aiding our quality engineer's investigation, unfortunately the other than confirming the failure mode the picture was not clear enough to evaluate the device in any definitive detail.Based on investigation results to date, root cause for manufacturing process cannot be determined due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.

• Brand Name: BD CONNECTA¿ STOPCOCK WITH VALVE & EXTENSION TUBING
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 7751598
• MDR Text Key: 116393765
• Report Number: 9610847-2018-00244
• 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: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 394971
• Device Lot Number: 7247573
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other