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

Event Date 11/27/2020

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 patient end connection was loose.The following information was provided by the initial reporter: at the moment we have quite a lot of problems with the connecta.The end that is connected to the patient regularly loosens from the tube.Additional information from the customer: the tube became loose when high pressure (4mml/sec) contrast medium (omnipaque 300) was injected into the patient.This is standard (and has been done for years) in contrast examinations with the ct-scan.The contrast pump is connected to the patient's infusion via the bd tap/hose.When the tube came loose, blood leaked out of the patient (through the infusion) which made it "dirty".

Event Description

It was reported that connecta plus3 10cm white patient end connection was loose.The following information was provided by the initial reporter: at the moment we have quite a lot of problems with the connecta.The end that is connected to the patient regularly loosens from the tube.Additional information from the customer: -the tube became loose when high pressure (4mml/sec) contrast medium (omnipaque 300) was injected into the patient.This is standard (and has been done for years) in contrast examinations with the ct-scan.The contrast pump is connected to the patient's infusion via the bd tap/hose.-when the tube came loose, blood leaked out of the patient (through the infusion) which made it "dirty".

Manufacturer Narrative

H.6.Investigation: to aid in the investigation of this issue, physical samples were returned for evaluation by our quality engineer team.Through examination of the returned samples, the reported issue of disconnection between the tubing and the fitting component could be identified.The manufacturing and maintenance records were reviewed for provided batch number 0129551, and during the production process, a damaged spring was detected within one of the manufacturing stations.

• 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: 11069412
• MDR Text Key: 227039144
• Report Number: 9610847-2020-00429
• 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: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 394995
• Device Lot Number: 0129551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 02/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1