MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 10CM WHITE; STOPCOCK

Catalog Number 394995

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that connecta plus3 10cm white leaked before use.The following information was provided by the initial reporter: fluid leaking from back of 3 way tap.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 9/14/2020.H.6.Investigation: to aid in the investigation of this issue, one physical sample was returned for evaluation by our quality engineer team.Due to covid-19 concerns, the sample was examined through an unopened shipment bag and it was not functionally tested.A thorough investigation utilizing other methodologies and available information was completed to the best of our ability.Based on the examination of the product, no signs of damage resulting in leakage could be observed.A device history record review was performed for provided lot number 9245129 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.At this time, an exact cause related to the manufacturing process could not be identified for this incident.

Event Description

It was reported that connecta plus3 10cm white leaked before use.The following information was provided by the initial reporter: fluid leaking from back of 3 way tap.

• Brand Name: CONNECTA PLUS3 10CM WHITE
• 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: 10570936
• MDR Text Key: 208817956
• Report Number: 9610847-2020-00293
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 394995
• Device Lot Number: 9245129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other