STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD
Received Feb 4, 2021 · Event occurred Jan 9, 2021
Report 3006260740-2021-00220 · MDR key 11281083
Device
Generic name
Stand, Infusion
Manufacturer
C.r. Bard, Inc. (basd) -3006260740Model number
N/ACatalog number
CV0220
Lot number
JUCYF073
Product problems
- Patient-Device Incompatibility
- Patient-Device Incompatibility
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Erythema
- Foreign Body Reaction
- Skin Inflammation/ Irritation
- Erythema
- Foreign Body Reaction
- Skin Inflammation/ Irritation
Narrative
Additional Manufacturer Narrative
THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF JUCYF073 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDDISHNESS ON THE SKIN IN THE SECOND WEEK OF STATLOCK USAGE. PER COMPLAINANT FOLLOWS UP PATIENT ALLERGY IS UNKNOWN. PATIENT WAS TREATED WITH LEVOFLOXACIN ANTIBIOTIC FOR 5 DAYS. CURRENTLY, PATIENT WAS DISCHARGED AND WENT BACK HOME.
Description of Event or Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDDISHNESS ON THE SKIN IN THE SECOND WEEK OF STATLOCK USAGE. PER COMPLAINANT FOLLOWS UP PATIENT ALLERGY IS UNKNOWN. PATIENT WAS TREATED WITH LEVOFLOXACIN ANTIBIOTIC FOR 5 DAYS. CURRENTLY, PATIENT WAS DISCHARGED AND WENT BACK HOME.
Additional Manufacturer Narrative
H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE ANALYSIS, APPLICABLE FMEA DOCUMENTS, APPLICABLE MANUFACTURING RECORDS, AND LABELING. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT THAT THE STATLOCK STABILIZATION DEVICE CAUSE OR CONTRIBUTED TO THE REPORTED REDNESS ON THE SKIN COULD NOT BE VERIFIED FROM THE PHOTOGRAPH THAT WAS PROVIDED FOR INVESTIGATION. THE PHOTOGRAPH SHOWED BLUE TUBING THAT WAS CONSISTENT WITH A GROSHONG PICC EXTENDING FROM THE PATIENT¿S ARM. NO STABILIZATION DEVICE WAS OBSERVED ON THE PATIENT. THE PATIENT¿S SKIN EXHIBITED VARIABLE DISCOLORATION. THE OUTLINE OF THE STATLOCK STABILIZATION DEVICE COULD NOT BE DISCERNED IN THE DISCOLORATION. A YELLOW COLORED MATERIAL WAS OBSERVED ON THE PATIENT¿S SKIN. A REVIEW OF THE MANUFACTURING RECORDS REVEALED NO ANOMALIES ASSOCIATED WITH THIS COMPLAINT. ALTHOUGH THE CAUSE OF THE REPORTED REDNESS COULD NOT BE TRACED TO THE DEVICE, THE STATLOCK STABILIZATION DEVICE IS CONTRAINDICATED FOR KNOWN TAPE OR ADHESIVE ALLERGIES AND KNOWN SENSITIVITY TO BENZOIN. THE DIRECTIONS FOR USE INDICATE THAT THE STATLOCK STABILIZATION DEVICE SHOULD BE REPLACED AT LEAST EVERY 7 DAYS. H3 OTHER TEXT: EVALUATION FINDINGS ARE IN SECTION H11.