MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-06-13 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[47292070]
The manufacturing review of the subject lot identified component conditions that could have contributed to the reported issue. However, no deviations were initiated and during manufacturing, line fallout levels were unremarkable. The subject lot was conforming to all in-process and final inspection criteria. The progel kit contains two pre-loaded glass cartridges. Both of which are both manually loaded into the applicator housing by the user. The plunger is then inserted into the openings in the rear of the cartridges. It was reported that when the surgeon pushed the plunger to expel the progel, the vial cracked. The ifu instructs the user to "load each cartridge into the twin-chambered applicator housing. Gently press the cartridges to seat them into place. " in addition, it was not reported which glass cartridge had broke. Without the subject product or additional information, a definitive conclusion as to how the vial was cracked cannot be reached. The information provided by bard represents all of the known information at this time. Discarded by user facility.
Patient Sequence No: 1, Text Type: N, H10
[47292071]
Information as reported by the davol sales rep: it was reported that during a vat right upper and lower lobe wedge procedure, the surgeon requested 2 progel kits. The first kit was opened, prepared and used without any issues. The second kit was opened and prepared, as the surgeon pushed the plunger to expel the progel, the vial cracked. The surgeon continued to push the progel out of the syringe; however, noted only one component was spraying out. It was unclear if it was the albumin side or the peg side that was spraying. The surgeon stopped use of the device and retrieved another progel kit of the same lot number from the storage refrigerator. No patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00256 |
| MDR Report Key | 5721052 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-06-13 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-05-19 |
| Date Mfgr Received | 2016-05-19 |
| Device Manufacturer Date | 2016-03-31 |
| Date Added to Maude | 2016-06-13 |
| 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 | ANNA SMITH |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258449 |
| Manufacturer G1 | NEOMEND INC -2953195 |
| Manufacturer Street | 60 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROGEL PLUERAL AIR LEAK SEALANT |
| Generic Name | SEALANT, POLYMERIZING |
| Product Code | NBE |
| Date Received | 2016-06-13 |
| Catalog Number | PGPS002 |
| Lot Number | 160309-002 |
| Device Expiration Date | 2017-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAVOL INC., SUB. C.R. BARD, INC. |
| Manufacturer Address | 100 CROSSINGS BLVD. WARWICK RI 02886 US 02886 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-06-13 |