MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHITE 360DEG TUBE 10CM INDIA

Catalog Number 395095

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: the customer provided lot # 216210004241.This does not match the catalog number provided.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.(b)(4).

Event Description

It was reported that connecta white 360deg tube 10cm india leaked.The following information was provided by the initial reporter: leakage issue with connecta 10 cm.

Event Description

It was reported that connecta white 360deg tube 10cm india leaked.The following information was provided by the initial reporter: leakage issue with connecta 10 cm.

Manufacturer Narrative

H.6.Investigation: as no physical sample, picture sample, or valid lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Dhr could not be performed due to unknown lot#.H3 other text : see h.10.

• Brand Name: CONNECTA WHITE 360DEG TUBE 10CM INDIA
• 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: 11143486
• MDR Text Key: 227038743
• Report Number: 9610847-2021-00004
• 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: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 395095
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1