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 Known Impact Or Consequence To Patient (2692)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bd connecta¿ stopcock cap connection was loose before use and wouldn't hold water properly as a result.The cap reportedly fell off "directly" when opening up the packaging.The following information was provided by the initial reporter, translated from (b)(6) to english: "the caps don't hold water properly.The cap falls off directly while opening the packaging and is therefore not screwed tight.".

Manufacturer Narrative

H.6.Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd connecta¿ stopcock cap connection was loose before use and wouldn't hold water properly as a result.The cap reportedly fell off "directly" when opening up the packaging.The following information was provided by the initial reporter, translated from german to english: "the caps don't hold water properly.The cap falls off directly while opening the packaging and is therefore not screwed tight.".

• 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: 9956139
• MDR Text Key: 195314138
• Report Number: 9610847-2020-00129
• 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: 05/27/2020

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 Catalogue Number: 394995
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other