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

Catalog Number	740013
Health Effect - Clinical Codes	Erythema (1840); Unspecified Infection (1930); Rash (2033); Discharge (2225); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that as a result of the usage of our device, the patient experienced redness, raised skin, skin tear, drainage, and foul odor.The area of the allegedly infected skin was the same circumference as the libre pro continuous glucose monitor.Allegedly alcohol was used to clean the patient's skin before placing the protective barrier film on the skin.Then, a libre pro continuous glucose monitor was placed in the patients skin with a needle.The protective barrier film was used on the patients skin for 13 days.Allegedly, the patient visited a non-emergent care facility due to the experienced redness, raised skin, skin tear, drainage, and foul odor.It was later reported, the patient was prescribed an antibiotic called keflex and a topical antibiotic.The location of the alleged infected skin was on the patient's right arm.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "bard protective barrier film.Prescription only.Latex free.Catalog no.740013.Helps protect skin around wounds and stomas from irritation of exudate and digestive juices (active enzymes), urine and irritation caused by adhesives.Bonds to skin and helps prevent these irritants from coming in contact with sensitive areas.Also for use with external catheter to help protect against urine or adhesive irritation.Directions: prepare are by cleansing with a gentle skin cleanser.Rinse and dry thoroughly.Apply bard protective barrier film with wipe and allow to dry for 1 minute.Momentary sting will be felt when applied to excoriated skin.Contains: isopropanol, butyl ester of pvm/ma, acetyl tributyl citrate." (b)(4).
Event or Problem Description
It was reported that after use of the device, the patient experienced redness, raised skin, skin tear, drainage, and foul odor.The area of the allegedly infected skin was the same circumference as the libre pro continuous glucose monitor.Allegedly, alcohol was used to clean the patient's skin before placing the protective barrier film on the skin.Then, a libre pro continuous glucose monitor was placed in the patients skin with a needle.The protective barrier film was used on the patients skin for 13 days.Allegedly, the patient visited a non-emergent care facility due to the experienced redness, raised skin, skin tear, drainage, and foul odor.It was later reported, the patient was prescribed an antibiotic called keflex and a topical antibiotic.The location of the alleged infected skin was on the patient's right arm.

• Brand Name: BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES
• Common Device Name: PROTECTIVE BARRIER FILM WIPES
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6967582
• Report Number: 1018233-2017-05375
• Device Sequence Number: 16446827
• Product Code: EXB
• UDI-Device Identifier: 10801741072779
• UDI-Public: (01)10801741072779
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2017

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
• Operator of Device: Health Professional
• Device Catalogue Number: 740013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 11/09/2017
• Initial Report FDA Received Date: 10/21/2017
• Supplement Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention