MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA PLUS3 WHITE PEGS

Catalog Number 394601

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

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 white pegs leaked on 4 occasions.The following information was provided by the initial reporter: the longest valve of the connecta was leaking.

Event Description

It was reported that connecta plus3 white pegs leaked on 4 occasions.The following information was provided by the initial reporter: the longest valve of the connecta was leaking.

Manufacturer Narrative

H6: investigation summary: a device history record review was performed for provided lot number 0007715 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, the sample was returned for evaluation by our quality engineer team.Due to covid-19 safety precautions, the sample was only visually inspected.Through inspection, the luer-lock component was observed stuck on the sample product.At this time, an exact cause for the reported incident could not be determined.

• Brand Name: CONNECTA PLUS3 WHITE PEGS
• Type of Device: CONNECTA
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 10869829
• MDR Text Key: 218224475
• Report Number: 9610847-2020-00364
• 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: 12/22/2020

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 Expiration Date: 12/31/2022
• Device Catalogue Number: 394601
• Device Lot Number: 0007715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 12/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1