FDA Adverse Event
Malfunction
Summary report: N
BIOGLUE SURGICAL ADHESIVE
MDR report key: 11734248
·
Received April 27, 2021
Report
- Report Number
- 1063481-2016-70031
- Event Type
- Malfunction
- Date Received
- April 27, 2021
- Date of Event
- December 11, 2015
- Report Date
- April 27, 2021
- Manufacturer
- CRYOLIFE, INC.
- Product Code
- MUQ
- PMA / PMN Number
- P010003
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ACCORDING TO THE REPORT, "DURING OPEN HEART SURGERY, THE SURGEON DID DE-AIRING, DRY THE TARGET SITE, PRIMING THE SYRINGE AND APPLYING THE BIOGLUE TO THE TARGET SITE. BUT, THE SURGEON FELT BIOGLUE DID NOT POLYMERISE WELL LIKE BEFORE AND JUST FLOWED DOWN. SO, HE OPENED ANOTHER 2 EA. OF BIOGLUE, AND APPLIED TO THE TARGET SITES AGAIN, BUT HE FELT SAME SITUATION. FINALLY, HE USED 3 EA. OF BIOGLUE 5ML FOR 1 PATIENT, AND COMPLETED THIS OPERATION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631975 | BIOGLUE SURGICAL ADHESIVE | GLUE, SURGICAL, ARTERIES | MUQ | CRYOLIFE, INC. | BG3515-5-US | 15MUV027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |