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

Catalog Number 394910

Device Problem Leak/Splash (1354)

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

Event Date 09/18/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 during use the stopcocks are leaking from the turn valve with a bd connecta plus1 360 white blend.The following information was provided by the initial reporter: it was reported that the stopcocks are leaking from around the turn valve.They leak from around the turn valve.Sometimes its a few drops but most often its is a few cc by the end of the procedure.It is enough that i have to place a 4x4 down to not make a wet spot on the bed or patients gown.That is medication that is not getting to the patient for the nerve block.

Manufacturer Narrative

H.6.Investigation summary: a lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample was not submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.

Event Description

It was reported that during use the stopcocks are leaking from the turn valve with a bd connecta plus1 360 white blend.The following information was provided by the initial reporter: it was reported that the stopcocks are leaking from around the turn valve.They leak from around the turn valve.Sometimes its a few drops but most often its is a few cc by the end of the procedure.It is enough that i have to place a 4x4 down to not make a wet spot on the bed or patients gown.That is medication that is not getting to the patient for the nerve block.

• Brand Name: BD CONNECTA PLUS1 360 WHITE BLEND
• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9157075
• MDR Text Key: 169086078
• Report Number: 9610847-2019-00603
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/09/2019

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: 394910
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/04/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/09/2019
• 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
• Patient Outcome(s): Other