BIOGLUE SYRINGE 5-PACK, 5ML, G
Report
- Report Number
- 1063481-2024-00018
- Event Type
- Injury
- Date Received
- July 10, 2024
- Date of Event
- May 7, 2024
- Report Date
- September 16, 2024
- Manufacturer
- ARTIVION, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ACCORDING TO THE SALES REPRESENTATIVE, LOT NUMBER WAS NOT KNOWN, NO CULTURES WERE PROVIDED, AND NO ACTIONS WERE TAKEN AS A RESULT OF THIS EVENT. A SIX-MONTH QUERY WAS PERFORMED TO OBTAIN LOT NUMBERS THAT WERE SHIPPED TO THIS FACILITY: BG001034, BG001049, BG001074, BG001080 AND BG001084. THE MANUFACTURING RECORDS FOR BG3515-5-G, LOTS BG001034, BG001049, BG001074, BG001080 AND BG001084 WERE REVIEWED, AND IT WAS CONFIRMED THAT ALL RECORDS WERE CONTROLLED, AVAILABLE FOR REVIEW, AND MET ALL SPECIFICATIONS PER THE DEVICE MASTER RECORD. ALL LOTS PASSED FUNCTIONAL TESTING AND MET RELEASE SPECIFICATIONS. DURING THE INVESTIGATION NO NON-CONFORMANCES OR DEVIATIONS WERE FOUND TO BE RELATED TO THE COMPLAINT. THE INFORMATION PROVIDED IS VERY LIMITED. THE FOLLOWING INFORMATION WAS NOT PROVIDED AND IS UNKNOWN: THE SPECIFIC TYPE OF SURGERY PERFORMED, THE CONDITION OF THE NATIVE TISSUE, IF ANY OTHER PRODUCTS WERE USED DURING THE PROCEDURE, AND ANY CO-MORBIDITIES THE PATIENT MAY HAVE HAD. BIOGLUE UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESSING STEP, THEREFORE, THE SOURCE OF ANY POTENTIAL INFECTION IS LIKELY NOT RELATED TO BIOGLUE. EXCESSIVE USE OF BG (BIOGLUE) MAY CAUSE A ROBUST UNINTENDED INFLAMMATORY REACTION WHICH IS CONSISTENT WITH THE DESCRIBED CLINICAL REACTION. AS NOTED IN THE IFU, BIOGLUE IS STERILIZED USING ETHYLENE OXIDE AND IRRADIATION. INFECTION AND/OR INFLAMMATION ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS. THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE INFECTION. BIOGLUE UNDERGOES A VALIDATED TERMINAL STERILIZATION PROCESSING STEP, THEREFORE THE SOURCE OF ANY POTENTIAL INFECTION IS LIKELY NOT RELATED TO BIOGLUE. AS NOTED IN THE IFU, BIOGLUE IS STERILIZED USING ETHYLENE OXIDE AND IRRADIATION. INFECTION AND/OR INFLAMMATION ARE LISTED IN THE IFU AS POTENTIAL ADVERSE EVENTS. BASED ON THE LIMITED INFORMATION AVAILABLE, NO DEFINITIVE CONCLUSION CAN BE MADE. RISK HAS BEEN REDUCED AS LOW AS POSSIBLE AND OVERALL RESIDUAL RISK IS ACCEPTABLE. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
THIS INVESTIGATION IS CURRENTLY ONGOING. ANY ADDITIONAL INFORMATION WILL BE PROVIDED IN THE FOLLOW-UP REPORT. THIS REPORT IS BEING SUBMITTED AS REQUIRED BY FEDERAL REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. FURTHERMORE, THIS REPORT REFLECTS THE EVENT AS ALLEGED BY THE COMPLAINANT AND DOES NOT IMPLY THAT THE INFORMATION REPORTED TO ARTIVION IS ACCURATE OR HAS BEEN CONFIRMED BY ARTIVION.
ACCORDING TO THE INITIAL REPORT, "STERILE INFECTION FROM FOREIGN BODY REACTION BY USING TOO MUCH BIOGLUE IN SPINAL CASE. 5ML USED AND 2 ML WAS RECOMMENDED." THIS PATIENT REQUIRED SURGICAL INTERVENTION AS A RESULT.
ACCORDING TO THE INITIAL REPORT, "STERILE INFECTION FROM FOREIGN BODY REACTION BY USING TOO MUCH BIOGLUE IN SPINAL CASE. 5ML USED AND 2 ML WAS RECOMMENDED." THIS PATIENT REQUIRED SURGICAL INTERVENTION AS A RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2144481 | BIOGLUE SYRINGE 5-PACK, 5ML, G | GLUE,SURGICAL,ARTERIES | MUQ | ARTIVION, INC. | BG3515-5-G | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |