MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 25CM; STOPCOCK

Catalog Number 394926

Device Problem Leak/Splash (1354)

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

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the connecta wht 360deg tb 25cm leaked medication during use.The following information was provided by the initial reporter, translated from spanish to english: "the nurse of several services has reported that the medication is leaking the 3-way key".

Event Description

It was reported that the connecta wht 360deg tb 25cm leaked medication during use.The following information was provided by the initial reporter, translated from spanish to english: "the nurse of several services has reported that the medication is leaking the 3-way key".

Manufacturer Narrative

H.6.Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: CONNECTA WHT 360DEG TB 25CM
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 9812201
• MDR Text Key: 195308360
• Report Number: 9610847-2020-00091
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

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: Health Professional
• Device Catalogue Number: 394926
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/10/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other