C.R. BARD, INC. (COVINGTON) -1018233 BARD PROTECTIVE BARRIER FILM INDIVIDUAL WIPES; PROTECTIVE BARRIER FILM WIPES
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Catalog Number 740013 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Erythema (1840); Unspecified Infection (1930); Rash (2033); Discharge (2225); Skin Tears (2516)
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Event Type
Injury
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Manufacturer Narrative
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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.
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Event Description
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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.
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Manufacturer Narrative
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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).
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Event Description
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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.
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