MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES; BARRIER WIPES

Catalog Number 740013

Device Problems Failure To Adhere Or Bond (1031); Device Reprocessing Problem (1091)

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

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 was not returned.

Event Description

It was reported that the wipes did not clean the patient's skin thoroughly; as a result his diabetic equipment did not adhere properly.

Manufacturer Narrative

Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.

Event Description

It was reported that the wipes did not clean the patient's skin thoroughly; as a result his diabetic equipment did not adhere properly.

• Brand Name: BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES
• Type of Device: BARRIER WIPES
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6826520
• MDR Text Key: 84098609
• Report Number: 1018233-2017-04496
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 10801741072779
• UDI-Public: (01)10801741072779
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 740013
• Device Lot Number: BMBNAP01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 08/09/2017
• Supplement Dates FDA Received: 08/30/2017
• 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