MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC; INTERVASCULAR CATHETER

Catalog Number 382523

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Infiltration into Tissue (1931); Ulcer (2274); No Code Available (3191)

Event Date 12/13/2018

Event Type  Injury  

Manufacturer Narrative

Device expiration date: unknown.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause is undetermined.No sample, lot, or batch provided.Device manufacture date: unknown.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) insyte autoguard bc caused an infection ultimately resulting in amputation with the customer saying ¿it was reported that three days after placement it was found that the catheter had infiltrated and a wound had formed.The patient contracted an infection of the right foot and right leg and had a large ulcer on the dorsal right foot.After consultation with doctors, the patient elected to proceed with right, below-knee amputation.¿.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) INSYTE AUTOGUARD BC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8383961
• MDR Text Key: 137659719
• Report Number: 1710034-2019-00232
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903825233
• UDI-Public: 00382903825233
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110443
• 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
• Report Date: 02/14/2019

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?: No
• Device Operator: Other
• Device Catalogue Number: 382523
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 03/01/2019
• 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
• Patient Age: 71 YR
• Patient Weight: 77