MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHITE 360DEG TUBE 100CM; STOPCOCK

Catalog Number 395061

Device Problem Leak/Splash (1354)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Initial reporter addr 1: (b)(6).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 connecta white 360deg tube 100cm experienced leakage.The following information was provided by the initial reporter: when using connecta 10cm during procedure (when infusing with syringe in connecta 100cm), there was a leakage.

Event Description

It was reported that the connecta white 360deg tube 100cm experienced leakage.The following information was provided by the initial reporter: when using connecta 10cm during procedure( when infusing with syringe in connecta 100cm), there was a leakage.

Manufacturer Narrative

H6: investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.Based on the limited investigation results, a cause for the reported incident could not be determined.See h10.

• Brand Name: CONNECTA WHITE 360DEG TUBE 100CM
• 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: 10952632
• MDR Text Key: 232567224
• Report Number: 9610847-2020-00392
• 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: 03/11/2021

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: Other
• Device Catalogue Number: 395061
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/10/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1