MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA PLUS1 360 WHITE BLEND; STOPCOCK, I.V. SET

Catalog Number 394910

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.

Event Description

It was reported that bd connecta plus1 360 white blend component was damaged and leaked.The following information was provided by the initial reporter; verbatim: rcc received complaint via email.Email(s) attached.It was reported by customer that leaks and cracks after few minutes of using it causing leaks of chemotherapy drugs.I need to know what material this stopcock is made out of? it's called bd connects with ref #394910.We are looking for a 3-way-luer-lock-stopcock that is resistance to lipiodol.This one is not and leaks and cracks after few minutes of using it causing leaks of chemotherapy drugs.

Manufacturer Narrative

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.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.H3 other text : see narrative below.

• Brand Name: BD CONNECTA PLUS1 360 WHITE BLEND
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18080345
• MDR Text Key: 328429675
• Report Number: 9610847-2023-00294
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00382903949106
• UDI-Public: (01)00382903949106
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394910
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1