3202674-005 REDIPAK 1P 10B 50C
Report
- Report Number
- 1219103-2022-00344
- Event Type
- Malfunction
- Date Received
- January 19, 2022
- Report Date
- August 9, 2022
- Manufacturer
- CARDINAL HEALTH
- Product Code
- MKJ
- UDI-DI
- 00681490580656
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
THE DEVICE HISTORY RECORD (DHR) FOR LOT 826053 WAS REVIEWED FOR BOTH THE FINISHED GOOD AND THE SUB-ASSEMBLIES MANUFACTURED AT THE PLANT, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCTS THAT COULD HAVE LED TO THE REPORTED CONDITION. THE DHR REVIEW SHOWS THAT ALL ACCEPTANCE CRITERIA INSPECTIONS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THIS INCLUDES TESTING WHERE THE LINER IS PEELED FROM THE GEL BODY ELECTRODE AND INSPECTED FOR DELAMINATION. THIS PRODUCT WAS MANUFACTURED BETWEEN 2-OCT-2018 AND 5-OCT-2018. A SAMPLE WAS RECEIVED IN THE FORM OF A PHOTO. THE PHOTO SHOWS AN OPEN ELECTRODE ON A POUCH CONTAINING THE INFORMATION FOR THE REPORTED LOT. THIS INFORMATION INCLUDED THE EXPIRATION DATE FOR THE PRODUCT OF 25-MAR-2021, THIS INDICATED THE PRODUCT HAS BEEN EXPIRED FOR MORE THAN NINE MONTHS. THERE WERE NO IN-HOUSE SAMPLES AS THE PRODUCT IS WELL PAST THE EXPIRATION DATE. GEL DELAMINATION OCCURS WHEN THE GEL-TO-RELEASE LINER BOND STRENGTH IS GREATER THAN THE COHESIVE STRENGTH OF THE GEL OR GREATER THAN THE GEL-TO-SUBSTRATE BOND STRENGTH. THE DIFFERENCE IN BOND STRENGTH CAN CAUSE THE GEL TO PEEL FROM THE SUBSTRATE AND/OR TEAR. DELAMINATION IS CATEGORIZED AS FOLLOWS: AN AESTHETIC DELAMINATION DEFECT IS CHARACTERIZED BY A PERMANENT SEPARATION OF THE HYDROGEL FROM THE SUBSTRATE, EXPOSING THE UNDERLYING CARBON VINYL WITH LITTLE (I.E., AREA LESS THAN 1/8-INCH X 1/8 INCH) OR NO HYDROGEL REMAINS ON THE RELEASE LINER. ALSO, NO SILVER/SILVER CHLORIDE INK IS EXPOSED. AESTHETIC DELAMINATION DEFECTS WILL NOT SIGNIFICANTLY AFFECT ELECTRODE FUNCTION BUT MAY DISPLEASE THE CLINICIAN. FUNCTIONAL DELAMINATION IS A PERMANENT SEPARATION OF THE HYDROGEL FROM THE SUBSTRATE SUCH THAT THE SILVER/SILVER CHLORIDE INK REMAINS EXPOSED. ADDITIONALLY, PER OUR PROCEDURE, THERE SHALL BE NO LESS THAN 55% HYDROGEL REMAINING ON THE ADULT ELECTRODE WHEN THE RELEASE LINER IS REMOVED FROM THE ELECTRODE. THERE SHALL BE NO LESS THAN 78% HYDROGEL REMAINING ON THE ADULT ELECTRODE, WHEN THE AREA OF SEPARATION INCLUDES THE AREA OF UNDERLYING CONDUCTIVE MAT. WITH LOSS OF THE HYDROGEL NO MORE THAN THE PERCENTAGES AS DEFINED ABOVE THE ELECTRODES RETAIN FUNCTIONALLY ESSENTIAL PERFORMANCE; HOWEVER, THE REDUCTION IN THE HYDROGEL AREA WITH THE SILVER/SILVER CHLORIDE INK BEING EXPOSED MAY CAUSE AN INCREASE IN CURRENT DENSITY ACROSS THE REMAINING GEL AREA. THIS INCREASES THE POTENTIAL FOR SKIN IRRITATION AND BURNS. FROM A ROOT CAUSE ANALYSIS PERSPECTIVE, IT WAS NOT POSSIBLE TO DETERMINE A SPECIFIC ROOT CAUSE HOWEVER THE PRODUCT WAS WELL PAST THE EXPIRATION DATE WHICH COULD HAVE CONTRIBUTED TO THE GEL DELAMINATION. AS THIS PRODUCT IS WELL PAST THE EXPIRATION DATE NO FURTHER ACTIONS ARE REQUIRED. WE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS.
UPDATED SECTION D2 PRODUCT CODE FROM DRO TO MKJ.
THE CUSTOMER REPORTED THAT THE ELECTRODE EXHIBITED DELAMINATION. PER ADDITIONAL INFORMATION RECEIVED, THE DELAMINATION OCCURRED BEFORE USE ON THE PATIENT AND THERE WAS NO IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1848167 | 3202674-005 REDIPAK 1P 10B 50C | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | CARDINAL HEALTH | PM20022 | 826053 | 00681490580656 |
| 781657 | 3202674-005 REDIPAK 1P 10B 50C | AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) | MKJ | CARDINAL HEALTH | PM20022 | 826053 | 00681490580656 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |