Protective Barrier Film 740013Recalls & reported problems
C. R. Bard, Inc. · Protective Barrier Film · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10801741072779), received between Aug 29, 2017 and Oct 21, 2017 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Device Reprocessing Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Device Reprocessing Problem1
- Failure To Adhere Or Bond1
Patient problems
- Discharge1
- Erythema1
- No Known Impact Or Consequence To Patient1
- Rash1
- Skin Tears1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryOct 21, 2017Adverse Event Without Identified Device or Use Problem
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.
Patient problems: Discharge; Erythema; Rash; Skin Tears; Unspecified Infection
MAUDE report 6967582 ↗MalfunctionAug 29, 2017Failure To Adhere Or Bond; Device Reprocessing Problem
IT WAS REPORTED THAT THE WIPES DID NOT CLEAN THE PATIENT'S SKIN THOROUGHLY; AS A RESULT HIS DIABETIC EQUIPMENT DID NOT ADHERE PROPERLY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6826520 ↗
Other Bandage, liquid, skin protectant devices
- APLICARE APLS1106Medline Industries, Inc. · Bandage, liquid, skin protectant4 reports
- No Sting Skin-Prep Prot. Spray 28ml US 66800709Smith & Nephew Medical Limited · Bandage, Liquid, Skin Protectant2 reports
- SKIN-PREP Wipes 420400, 420471Smith & Nephew Medical Limited · Bandage, Liquid, Skin Protectant1 report
- Medline MSC1500Medline Industries, Inc. · Bandage, liquid, skin protectant1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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