CUSTOM-PAK SURGICAL PROCEDURE PACK
Report
- Report Number
- 1644019-2024-00551
- Event Type
- Malfunction
- Date Received
- March 27, 2024
- Report Date
- June 6, 2024
- Manufacturer
- ALCON RESEARCH, LLC - HOUSTON
- Product Code
- LRO
- PMA / PMN Number
- K880961
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD TRACEABLE TO THE REPORTED LOT NUMBER INDICATES THAT THE PRODUCT WAS PROCESSED AND RELEASED ACCORDING TO THE PRODUCT¿S ACCEPTANCE CRITERIA. THE MANUFACTURER'S EVALUATION OF THE RETURNED SAMPLE CONFIRMS THE CUSTOMER'S REPORTED EVENT: 35 UNOPENED AND 1 OPENED PAK SAMPLES WERE VISUALLY INSPECTED. THE CONTENT LABELS MARKED AN ASTERISK TO SHOW, "6.5 AND 7.5 GLOVES CONTAINS NATURAL RUBBER LATEX WHICH MAY CAUSE ALLERGIC REACTIONS." THE OPENED PAK CONTAINED TWO 6.5 LATEX FREE AND POWDER FREE PERFUSION INDEX (PI) CLASSIC SURGICAL GLOVES AND ONE 7.0 SENSICARE PI WITH ALOE VERA, WHICH SHOULD NOT BELONG TO THE PACKAGE.THE 7.5 GLOVES WERE MISSING IN THE PAK. THE 7.5 LATEX BUT POWDER FREE MICRO SURGICAL GLOVES, 6.5 AND 7.0 LATEX FREE AND POWDER FREE PI CLASSIC SURGICAL GLOVES WERE BUILT IN THE 35 UNOPENED CUSTOM PAK SAMPLES. THE 7.5 GLOVES WAS MISSING IN ONE OF THE UNOPENED PAK. A REVIEW OF THE DEVIATION HISTORY REPORT SHOWS THIS FINISHED GOODS LOT HAD A TEMPORARY DEVIATION APPLIED FOR THE UNAVAILABLE COMPONENT (NON-LATEX) TO BE SUBSTITUTED WITH AVAILABLE ALTERNATIVE (LATEX). THE ROOT CAUSE FOR THE REPORTED EVENT IS DUE TO AN APPROVED TEMPORARY DEVIATION. THE DEVIATION WAS TO SUBSTITUTE UNAVAILABLE COMPONENT FOR AVAILABLE ALTERNATIVE (LATEX). HOWEVER, THE ROOT CAUSE FOR THE NON-LATEX TO LATEX SUBSTITUTION IS DUE TO A SYSTEM INDICATOR NOT PROGRAMMED WITHIN THE SYSTEMS, APPLICATIONS AND PRODUCTS (SAP) DEVIATION TABLE TO PREVENT DEVIATING FROM NON-LATEX TO LATEX. COMPANY HAS TAKEN ACTION TO DETERMINE ROOT CAUSE AND IMPLEMENT APPROPRIATE CORRECTIVE BASED ON OBSERVED TREND FOR COMPLAINTS OF A SIMILAR NATURE. TO ADDRESS ROOT CAUSES, THE FOLLOWING ACTION WAS TAKEN. THE ORDER PARTS LISTS WERE REVISED TO USE NON-LATEX GLOVES AS THE SUBSTITUTION. ALSO, PAK PLANNING ALIGNED WITH CENTER OF EXCELLENCE (SAP IT) TO CREATE AN ENHANCEMENT IN SAP DEVIATION TABLE TO PREVENT DEVIATING FROM A NON-LATEX COMPONENT TO A LATEX COMPONENT. THIS WILL PREVENT CUSTOMERS FROM RECEIVING LATEX ITEMS IN THEIR PAK IF THE ORIGINAL COMPONENTS ARE NON-LATEX. COMPLAINTS ARE CONTINUOUSLY MONITORED TO IDENTIFY PRODUCT AND/OR PROCESS AREAS WHERE THIS TYPE OF ISSUE IS OCCURRING. QUALITY ASSURANCE HAS REVIEWED THIS COMPLAINT AND WILL CONTINUE TO MONITOR DATA FOR EVIDENCE OF ADVERSE TRENDING AND TAKE FURTHER ACTION, AS APPROPRIATE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4). H.10 REFLECTS ALL RELATED REPORT NUMBERS ASSOCIATED WITH THIS PRODUCT EVENT THAT HAVE BEEN SUBMITTED AT THIS TIME.
INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).
A CUSTOMER REPORTED THAT THEY RECEIVED THE GLOVES WHICH CONTAINED LATEX. THERE WAS NO PATIENT HARM. THE PROCEDURE DETAILS WERE UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2047690 | CUSTOM-PAK SURGICAL PROCEDURE PACK | GENERAL SURGERY TRAY (KIT) | LRO | ALCON RESEARCH, LLC - HOUSTON | NA | 15J7CD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | CUSTOM-PAK| CUSTOM-PAK |