MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. ANESTHESIA KIT DURASAFE 18X3-1/2

Catalog Number 400714

Device Problem Leak/Splash (1354)

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

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: since 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 has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.Investigation conclusion: a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in your description of the event.Root cause description: a root cause of the failure mode identified in your description of the event.

Event Description

It was reported that a defective connector was found during use with a anesthesia kit durasafe 18x3-1/2.The following information was provided by the initial reporter, "the anesthesia kit catheter (perisafe or durasafe) was removed from the home pop infusion pump.He refers in the call that they calculate are like ten occasions that have happened at different times, samples in photo were requested to see connection.And if it happened again the product lot will be taken." 10 occurrences were reported.

• Brand Name: ANESTHESIA KIT DURASAFE 18X3-1/2
• Type of Device: ANESTHESIA KIT
• 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: 9541149
• MDR Text Key: 195274299
• Report Number: 9610847-2019-00798
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400714
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2019
• 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