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

Catalog Number 394600

Device Problem Leak/Splash (1354)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/10/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9099769.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-05-07.Medical device lot #: 9094783.Medical device expiration date: 2022-03-31.Device manufacture date: 2019-04-25.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 detached during use.This was discovered during use.The following information was provided by the initial reporter: valve disconnects during the mobilization of the patient while the assembly has been checked beforehand.Incident reported 2 times on (b)(6) 2019 (2 different patients).Consequences for patients: discontinuation of the administration of norepinephrine hypotension observed.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 9099769.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue and encourages you to submit your sample for review.Conclusion: bd was not able to confirm the customer¿s indicated failure mode on the picture provided; sample is required to perform an evaluation.

Event Description

It was reported that bd connecta¿ stopcock detached during use.This was discovered during use.The following information was provided by the initial reporter: valve disconnects during the mobilization of the patient while the assembly has been checked beforehand.Incident reported 2 times on (b)(6) 2019 (2 different patients).Consequences for patients: discontinuation of the administration of norepinephrine hypotension observed.

• 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: 9245055
• MDR Text Key: 192048085
• Report Number: 9610847-2019-00643
• 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: 12/04/2019

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 Catalogue Number: 394600
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 10/10/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other