MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. GUARDIVA ANTIMICROBIAL HEMOSTATIC IV DRESSING; DRESSING, WOUND, DRUG

Model Number FP-23-AD008

Device Problem Material Disintegration (1177)

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

Event Date 03/05/2019

Event Type  malfunction  

Event Description

The patch itself is coming apart and not remaining in one piece with use.The patch comes apart, sticks to packaging, layers peel apart, etc.Manufacturer response for antimicrobial hemostatic iv dressing, guard iva (per site reporter).They removed product from hospital and replaced with alternative device.Multiple lot numbers identified.This is three lot numbers of many: jucsf230, jucuf003, asbyt002 250804.

• Brand Name: GUARDIVA ANTIMICROBIAL HEMOSTATIC IV DRESSING
• Type of Device: DRESSING, WOUND, DRUG
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 8393988
• MDR Text Key: 137976366
• Report Number: 8393988
• Device Sequence Number: 1
• Product Code: FRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FP-23-AD008
• Device Catalogue Number: FP-23-AD008
• Device Lot Number: JUCSF230
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/05/2019
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1