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 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

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 leaked and had foreign matter.This was discovered during use.The following information was provided by the initial reporter: today we had a strange leakage from a 3-way connecta 10cm.Strange because there is a filament running along the closing cap.I think that the leakage occurred because the cap does not close properly.Fortunately with apd and not with chemo!.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9158825.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To further investigate this issue, one physical sample was provided for evaluation by our quality engineer team along with picture samples.Through examination of the physical sample, foreign matter was detected; however, a leakage test was not performed as the sample returned was an incomplete device.Fourier-transform infrared spectroscopy was performed on the foreign matter and the matter was identified as a combination of polypropylene, polycarbonate, and ethylene vinyl acetate.A manufacturing related cause could not be determined based on the investigation results and foreign matter identification.

Event Description

It was reported that bd connecta¿ stopcock leaked and had foreign matter.This was discovered during use.The following information was provided by the initial reporter: today we had a strange leakage from a 3-way connecta 10cm.Strange because there is a filament running along the closing cap.I think that the leakage occurred because the cap does not close properly.Fortunately with apd and not with chemo!.

• 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: 9416089
• MDR Text Key: 192051469
• Report Number: 9610847-2019-00715
• 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: 03/18/2020

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: 05/31/2022
• Device Catalogue Number: 394995
• Device Lot Number: 9158825
• Initial Date Manufacturer Received: 11/20/2019
• Initial Date FDA Received: 12/05/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other