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 Problem Gas/Air Leak (2946)

Patient Problem Pulmonary Embolism (1498)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8184942; medical device expiration date: 2021-06-30; device manufacture date: 2018-08-29; medical device lot #: 7181507; medical device expiration date: 2020-05-31; device manufacture date: 2017-07-20.Date of event: unknown.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 there were +/- 30 incidents were a bd connecta¿ stopcock with valve & extension tubing leaked during use.It was also reported that one patient suffered a pulmonary embolism due to air related to the leakage.It is unknown if medical interventions were provided or if there was a change in treatment for this patient.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8213741 and 7181507.Our records show that this is the only instance of this issue occurring in either 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.Additionally, our engineers were able to duplicate this event through the leakage testing of the submitted device.A subsequent review of our manufacturing line determined that the most likely root cause for this event is an abnormality in the equipment responsible for tubing assembly.

Event Description

It was reported that there were +/- 30 incidents were a bd connecta¿ stopcock with valve & extension tubing leaked during use.It was also reported that one patient suffered a pulmonary embolism due to air related to the leakage.It is unknown if medical interventions were provided or if there was a change in treatment for this patient.

• 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: 8283571
• MDR Text Key: 134302212
• Report Number: 9610847-2019-00110
• 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: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394971
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2018
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other