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

Catalog Number 394600

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

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 medicine and solution leaked from the bd connecta¿ stopcock connection between the central body and white switch tap during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the users report leak of drugs and solutions in the part where there is the connection between the transparent polycarbonate central body and the white switch tap.The stopcocks are connected to maxzero valves which are connected to the connections of a cvc.Both connections not connected to the central body are connected to the extensions connected to infusion pumps." "partial leakage of drugs may result in partial administration of prescribed drugs and lack of therapeutic effect.If the staff does not notice the loss quickly, the problem may result in the partial loss of infusion drugs and not have therapeutic effect.In case of administration of drugs for the maintenance of the pharmacologically induced coma the patient may wake up.".

Event Description

It was reported that medicine and solution leaked from the bd connecta¿ stopcock connection between the central body and white switch tap during use.The following information was provided by the initial reporter, translated from italian to english: "the users report leak of drugs and solutions in the part where there is the connection between the transparent polycarbonate central body and the white switch tap.The stopcocks are connected to maxzero valves which are connected to the connections of a cvc.Both connections not connected to the central body are connected to the extensions connected to infusion pumps."."partial leakage of drugs may result in partial administration of prescribed drugs and lack of therapeutic effect.If the staff does not notice the loss quickly, the problem may result in the partial loss of infusion drugs and not have therapeutic effect.In case of administration of drugs for the maintenance of the pharmacologically induced coma the patient may wake up.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/20/2021.H.6.Investigation: a device history record review was completed for provided lot number 0064463.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.To aid in the investigation of this issue, nine samples were returned for evaluation by our quality engineer team.Inspection and leakage testing was performed for the returned samples and no negative results were concluded.Based on the investigation results, a cause related to the manufacturing process could not be determined for this reported incident.

• 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: 11101599
• MDR Text Key: 226861122
• Report Number: 9610847-2020-00440
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 394600
• Device Lot Number: 0064463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1