MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA WHITE 360DEG SHELF 100EA INDIA; STOPCOCK, I.V. SET

Catalog Number 395000

Device Problems Complete Blockage (1094); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/29/2021

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.

Event Description

It was reported when using the bd connecta white 360deg shelf 100ea india, the device experienced leakage, and flow issues.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: while they were trying to flush, fluid leaking observed at the connection site of cannula and connecta.Back flow seen in connecta despite locking.

Manufacturer Narrative

H.6.Investigation: our quality engineer inspected the 1 photo submitted for evaluation.The reported issue was not confirmed upon inspection of the photo.In order to confirm the reported failure, a physical sample is needed for the investigation.Bd cannot confirm the cause of the failure to our manufacturing process since no sample was returned for evaluation.A device history record review showed no non-conformances associated with this issue during the production of this batch.

Event Description

It was reported when using the bd connecta white 360deg shelf 100ea india, the device experienced leakage, and flow issues.This event occurred 4 times.The following information was provided by the initial reporter.The customer stated: while they were trying to flush, fluid leaking observed at the connection site of cannula and connecta.Back flow seen in connecta despite locking.

• Brand Name: BD CONNECTA WHITE 360DEG SHELF 100EA INDIA
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13333365
• MDR Text Key: 284296822
• Report Number: 9610847-2022-00021
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K850280
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 395000
• Device Lot Number: 1120604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1