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

Catalog Number 394945

Device Problems Infusion or Flow Problem (2964); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2020

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 tubing was kinked during use and prevented drug flow into the patient.This occurred on 25 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "the customer informs that several eaches in lot 9337119b have the same issue with the connecta stopcock with extension set; the tube is so bent that it cannot be straightened and therefore prevents the flow of drugs into the patient.This problem has occured several times and customer considers this a patient safety issue.Last year they had the same issue for several months with the same product.".

Event Description

It was reported that the bd connecta¿ stopcock tubing was kinked during use and prevented drug flow into the patient.This occurred on 25 separate occasions, but the dates and/or patient information are unknown.The following information was provided by the initial reporter: "the customer informs that several eaches in lot 9337119b have the same issue with the connecta stopcock with extension set; the tube is so bent that it cannot be straightened and therefore prevents the flow of drugs into the patient.This problem has occured several times and customer considers this a patient safety issue.Last year they had the same issue for several months with the same product.".

Manufacturer Narrative

The following fields were updated due to additional information: d10.Device available for eval?: yes.D10.Returned to manufacturer on: 6/4/2020.H6.Investigation: a device history record review was performed for provided lot number 9337119.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this incident, one unused sample was received for evaluation by our quality engineer team.Through examination of the sample, the tubing was observed kinked.The tubing was measured and the length was found to be within specifications; however, the length was close to the lower specification limit which could have contributed to the observed defect.In response to this incident, a quality alert has been issued to increase the awareness of this potential defect on the production floor.H3 other text : see h10.

• 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: 10105716
• MDR Text Key: 204773758
• Report Number: 9610847-2020-00164
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 394945
• Device Lot Number: 9337119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Date Manufacturer Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other