MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-28 for BIOGLUE SYRINGE 5-PACK, 2ML, US BG3502-5-US manufactured by Cryolife, Inc..
[140224003]
This investigation is currently ongoing. Any additional information will be provided in the follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[140224004]
According to the initial report, a post operative infection occurred. According to the complainant, patient is still being followed as of (b)(6) 2019. On (b)(6) 2018: cultured for staphylococcus aureus. On (b)(6) 2019: light growth of enterococcus faecalis and light growth of streptococcal a. Additional information was received. "the infection that occurred at our facility was on a patient who had a lumbar laminectomy on (b)(6) 2018. We brought her back to the or [operating room] on (b)(6) when it was discovered that she had a csf [cerebrospinal fluid leak] leak from her initial surgery that required repair. The [product] was used for the second surgery, when the surgeon placed a blood patch to repair the csf leak. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063481-2019-00014 |
| MDR Report Key | 8461873 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-28 |
| Date of Report | 2019-07-25 |
| Date Facility Aware | 2019-03-05 |
| Date Mfgr Received | 2019-03-05 |
| Date Added to Maude | 2019-03-28 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ROCHELLE MANEY |
| Manufacturer Street | 1655 ROBERTS BLVD. NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal | 30144 |
| Manufacturer Phone | 7704193355 |
| Manufacturer G1 | CRYOLIFE, INC. |
| Manufacturer Street | 1655 ROBERTS BLVD., NW |
| Manufacturer City | KENNESAW GA 30144 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30144 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BIOGLUE SYRINGE 5-PACK, 2ML, US |
| Generic Name | GLUE,SURGICAL,ARTERIES |
| Product Code | MUQ |
| Date Received | 2019-03-28 |
| Model Number | BG3502-5-US |
| Catalog Number | BG3502-5-US |
| Lot Number | 17MUW004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CRYOLIFE, INC. |
| Manufacturer Address | 1655 ROBERTS BLVD. NW KENNESAW GA 30144 US 30144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-03-28 |