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

Catalog Number 394995

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(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 that the bd connecta¿ stopcock connection was "not secure" and had "spontaneous disconnections" during use that led to drug leakage.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 8249629.Our records show that this is the only instance of a 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.Additionally the sample returned to our facility was reviewed and subjected to leakage testing; the testing results found he device to be operating according to product specifications.Further inspection of the device was unable to find any visual indications of damage or other non-conformances.Unfortunately without the duplication of the reported failure, the root cause for this complaint could not be determined at the conclusion of our review.

Event Description

It was reported that the bd connecta¿ stopcock connection was "not secure" and had "spontaneous disconnections" during use that led to drug leakage.

• 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
• MDR Report Key: 8302339
• MDR Text Key: 135358569
• Report Number: 9610847-2019-00120
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

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 Expiration Date: 08/31/2021
• Device Catalogue Number: 394995
• Device Lot Number: 8249629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2019
• Initial Date Manufacturer Received: 01/16/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other