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

Catalog Number 394997

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/21/2019

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 that an unspecified number of connecta plus3 10cm blue experienced tubing separation from the adapter/luer connector during use.The following information was provided by the initial reporter: bd connecta was connected to a venous catheter.When flushing with bd posiflush, the tubing has come off the connector.

Event Description

It was reported that an unspecified number of connecta plus3 10cm blue experienced tubing separation from the adapter/luer connector during use.The following information was provided by the initial reporter: bd connecta was connected to a venous catheter.When flushing with bd posiflush, the tubing has come off the connector.

Manufacturer Narrative

H.6.Investigation summary: a device history review was conducted for lot number 9066626.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample was submitted for evaluation and testing.Samples received were inspected visually and the used sample showed the separation apparently for lack of solvent, the sample received in package was visually inspected and this sample was in good condition also this sample was functional tested (leak and pull test) and the sample passed the tests.No abnormalities could be identified in the returned sample despite attempts to identify the cause using leakage testing and microscopic evaluation of the device.The root cause for this complaint could not be determined at the conclusion of our review.

• Brand Name: CONNECTA PLUS3 10CM BLUE
• Type of Device: STOP COCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9285818
• MDR Text Key: 191724350
• Report Number: 9610847-2019-00666
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 01/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 394997
• Device Lot Number: 9066626
• Date Manufacturer Received: 10/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other