MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-06-16 for PROGEL PLUERAL AIR LEAK SEALANT PGSSS008 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[47543925]
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 platinum 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
[47543926]
Information as provided by the user facility: it was reported that when attempting to apply the progel platinum, the device was damaged and the glass vial was noted to be cracked. The device was not used and another device was used to complete the case. The subject product is not marketed for us sales. A similar product is marketed in the us.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2016-00268 |
| MDR Report Key | 5729929 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-06-16 |
| Date of Report | 2016-05-24 |
| Date of Event | 2016-05-24 |
| Date Mfgr Received | 2016-05-24 |
| Device Manufacturer Date | 2016-01-05 |
| Date Added to Maude | 2016-06-16 |
| 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 | 2016-06-16 |
| Catalog Number | PGSSS008 |
| Lot Number | 160105-003 |
| Device Expiration Date | 2017-03-24 |
| 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 | 2016-06-16 |