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

Catalog Number 394997

Device Problem Leak/Splash (1354)

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

Event Date 01/10/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that connecta plus3 10cm blue leaked during use.The following information was provided by the initial reporter: the three-way taps leak when used with lipid-containing medication.

Event Description

It was reported that connecta plus3 10cm blue leaked during use.The following information was provided by the initial reporter: the three-way taps leak when used with lipid-containing medication.

Manufacturer Narrative

H.6.Investigation summary: a device history record review was performed for provided lot number 9039991.The review did not reveal any detected quality issues during the production process that could have contributed to this reported incident and all quality inspections were within specification.To further investigate this issue, two physical samples were provided for evaluation by our quality engineer team.The two samples were functionally tested for leakage, however, no signs of leakage were observed in either sample.Based on the investigation results, a manufacturing related cause for the reported incident could not be identified.Further action has not been determined at this time.Our quality team will continue to monitor the production process for signs of this potential defect and other emerging trends.

• Brand Name: CONNECTA PLUS3 10CM BLUE
• Type of Device: CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9647963
• MDR Text Key: 194707471
• Report Number: 9610847-2020-00028
• 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: 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394997
• Device Lot Number: 9039991B
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/10/2020
• Supplement Dates FDA Received: 02/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other