MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT DRESSING CHANGE KIT; DRESSING, WOUND, DRUG

Model Number N/A

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

Patient Problem Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device(s) has not been returned, to the manufacturer for evaluation.A lot history review (lhr) of 18db1081 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that 6 different patients had an adverse reaction to the dressing.All of these patients have used this kit in the past, but this is the first occurrence of this reaction.This file is reporting the first of six events reported.

• Brand Name: DOT DRESSING CHANGE KIT
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer Contact: heather murphy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225738
• MDR Report Key: 7958735
• MDR Text Key: 123486858
• Report Number: 3006260740-2018-02877
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: DC5090LF
• Device Lot Number: 18DB1081
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 09/19/2018
• 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