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 Consequences Or Impact To Patient (2199)

Event Date 09/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The reported lot #s 0092619c and 0062962d were not found for the reported catalog # 394995.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.(b)(4).

Event Description

It was reported that the bd connecta¿ stopcock leaked iron preparation fluid onto the nurse and patient during use.The following information was provided by the initial reporter, translated from (b)(6) to english, "unfortunately we have received another complaint about a leaking three-way tap ref 394995 from day room hematology." "did the defect lead to a serious injury? (for example, due to the incorrect dose of the drug being administered?) no.Was there a medical treatment as a result of this incident? no.Did the treatment plan have to be adjusted as a result of this incident? no.Was anyone exposed to the liquid that was leaking? patient and nurse; the infusion fluid was an iron preparation (injectafer).Other actions to be taken? 3way tap was replaced.".

Event Description

It was reported that the bd connecta¿ stopcock leaked iron preparation fluid onto the nurse and patient during use.The following information was provided by the initial reporter, translated from dutch to english: "unfortunately we have received another complaint about a leaking three-way tap ref (b)(4) from day room hematology." "-did the defect lead to a serious injury? (for example, due to the incorrect dose of the drug being administered?) no.Was there a medical treatment as a result of this incident? no.Did the treatment plan have to be adjusted as a result of this incident? no.Was anyone exposed to the liquid that was leaking? patient and nurse: the infusion fluid was an iron preparation (injectafer).Other actions to be taken? 3way tap was replaced.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-11-06.H6: investigation summary: a device history record review was performed for provided potential lot numbers 0092619 and 0062962.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.Prior to release, samples were obtained for leakage testing, and all results were acceptable.To aid in the investigation of this issue, two unused samples and one used sample were returned in the same package for evaluation by our quality team.Due to preventive safety measures in place for covid-19, the samples were visually inspected only.The three samples did not reveal any signs of damage or cracking.The assembly of the housing component looked to be per specification.Based on the investigation results, a manufacturing related cause could not be determined for this incident.The quality records have been consulted for tracking and trending purposes and we believe this was an isolated incident with a low chance of recurrence.

• 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: 10674275
• MDR Text Key: 213500642
• Report Number: 9610847-2020-00322
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 394995
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 09/22/2020
• Initial Date FDA Received: 10/13/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 11/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other