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 Radiation Overdose (1510)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

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.(b)(4).

Event Description

It was reported that while using bd connecta¿ stopcock the tubing broke.The patient had to have ct repeated, thus additional round of contrast given.Double amount of radiation also provided.The following information was provided by the initial reporter: the issue is regarding a broken tube.Course of treatment changed due to event: yes, double the amount of radiation; course of treatment changed due to event: yes, the ct process (contrast medium infusion) had to be repeated; exposure to blood/bodily fluid: no; medical int.Other than first aid: yes, possible damage to the kidney from contrast media; needle/probe stick; no; safety issue: yes, pressure problem with ct process; other actions taken: yes, more contrast media used than required.

Event Description

It was reported that while using bd connecta¿ stopcock the tubing broke.The patient had to have ct repeated, thus additional round of contrast given.Double amount of radiation also provided.The following information was provided by the initial reporter: the issue is regarding a broken tube.-course of treatment changed due to event: yes, double the amount of radiation; -course of treatment changed due to event: yes, the ct process (contrast medium infusion) had to be repeated; -exposure to blood/bodily fluid: no; -medical int.Other than first aid: yes, possible damage to the kidney from contrast media; -needle/probe stick; no; -safety issue: yes, pressure problem with ct process; -other actions taken: yes, more contrast media used than required.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 1/15/2021 h.6.Investigation: a device history record review was performed for provided lot number 0115358 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the physical sample was returned for evaluation by our quality engineer team.Through examination of the sample, the tube was observed detached from the product.Maintenance records were evaluated and no anomalies were identified that could have contributed to this defect.See h.10.

• 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: 10901994
• MDR Text Key: 218185038
• Report Number: 9610847-2020-00373
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 394995
• Device Lot Number: 0115358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention