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 06/02/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the bd connecta¿ stopcock experienced a stopcock/cap loose connection/separated/detached.Product defect was noted during use.The following information was provided by the initial reporter: customer reports: the connecta stopcock with extension set side connection cap is loose.The cap falls of when opening the package.June 2nd during an examination the cap fell off and radioactive medication was spilled on the nurses hands and also into a kidney bowl.This meant that the patient did not receive a sufficient amount of the radioactive drug and as a consequence the examination had to be repeated the next day.The customer also states that they can use the product provided you tighten up the side caps before use.Also in case the cap falls of they need an addition sterile cap at hand.Work safety and patient safety issue has been reported by the customer.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 0004292.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.The removal force quality test results for the plugs (caps) during the production process were reviewed and no results were found out of specification.As neither a physical sample nor a picture sample were available for evaluation by our quality engineer team, a thorough sample evaluation could not be completed.Per the product's instructions for use, the user should ensure that the plugs are tight prior to use.At this time, a manufacturing related cause could not be determined for this reported incident.

Event Description

It was reported that the bd connecta¿ stopcock experienced a stopcock/cap loose connection/separated/detached.Product defect was noted during use.The following information was provided by the initial reporter: customer reports: the connecta stopcock with extension set side connection cap is loose.The cap falls of when opening the package.(b)(6) during an examination the cap fell off and radioactive medication was spilled on the nurses hands and also into a kidney bowl.This meant that the patient did not receive a sufficient amount of the radioactive drug and as a consequence the examination had to be repeated the next day.The customer also states that they can use the product provided you tighten up the side caps before use.Also in case the cap falls of they need an addition sterile cap at hand.Work safety and patient safety issue has been reported by the customer.

• 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: 10191802
• MDR Text Key: 203180233
• Report Number: 9610847-2020-00191
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 394995
• Device Lot Number: 0004292
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other