MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2017-03-06 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[69204578]
The subject product was returned for evaluation and visually inspected. The peg glass cartridge and the albumin glass cartridge were both received physically fractured at the proximal push rod entry points. The second glass cartridge was broken, with a fragment missing and not returned. The contact reported that the vial cracked and no loose fragments were reported to have come free from the device. There are multiple ways that the cartridges could have become cracked during manufacturing and post manufacturing of the product. 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 lot number was not provided, therefore, a manufacturing review could not be performed. At this time, we are unable to reach a definitive conclusion as to when and 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
[69204579]
As reported by the davol sales rep: during a robotic thoracic lung resection, the or tech prepared the progel using proper technique. As the surgeon sprayed the progel onto the lung, it was noted that the liquid was coming out into the applicator housing of the device and noted that the vial within the applicator housing had cracked. There were no loose fragments within the applicator and nothing had come free from the device. Another progel was prepared and used without further issue resulting in only a very short delay to the case. Surgeon noted a slight resistance when beginning to spray ; however, noted it is not unusual to have a slight resistance before the progel is released. The vial was not identified as having been damaged at that time. There was no patient injury as a result of the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00153 |
| MDR Report Key | 6382310 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2017-03-06 |
| Date of Report | 2018-10-26 |
| Date Mfgr Received | 2018-10-12 |
| Date Added to Maude | 2017-03-06 |
| 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 | FRANCESCA SANTAMARIA |
| Manufacturer Street | 100 CROSSINGS BLVD. |
| Manufacturer City | WARWICK RI 02886 |
| Manufacturer Country | US |
| Manufacturer Postal | 02886 |
| Manufacturer Phone | 4018258538 |
| 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 | 2017-03-06 |
| Returned To Mfg | 2017-02-17 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| 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 | 2017-03-06 |