MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-07 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[69301078]
The subject product was returned for evaluation and visually inspected. The albumin glass cartridge was received physically fractured at the proximal push rod entry points. The broken fragment was returned with the sample. There were no signs of damage to the push rod or other components to indicate excessive force and no damage was reported at the beginning of use. A review of the manufacturing records was performed and found that the lot was manufactured to specification. There are multiple ways that the cartridges could have become cracked during manufacturing and post manufacturing of the product; however, it was reported that the tech was advancing the push rod and a noise was heard which prompted inspection of the cartridge. At this time, we are unable to reach a definitive conclusion as to how the vials were damaged. The ifu for the progel product prescribes the proper instructions and precautions for this device to inspect for damage to the product and to prevent damage to the product during use. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
Patient Sequence No: 1, Text Type: N, H10
[69301079]
As reported by the davol sales rep: during a vats lung resection, the or tech prepared the progel using proper technique. As the push rod was being advanced, a noise was heard which prompted inspection of the cartridge. It was noted that the cartridge was cracked. Another progel was prepared for the surgeon. The second progel was used without further issue. This resulted in a very short delay to the case and no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00157 |
| MDR Report Key | 6385691 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2017-02-10 |
| Date Mfgr Received | 2017-02-10 |
| Device Manufacturer Date | 2016-11-22 |
| Date Added to Maude | 2017-03-07 |
| 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 | 2017-03-07 |
| Returned To Mfg | 2017-02-17 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 161101-002 |
| Device Expiration Date | 2017-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 2017-03-07 |