MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-08-25 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[83730150]
The subject product was returned for evaluation and visually inspected. The albumin and peg glass cartridges were broken at the proximal push rod entry point of the cartridge. A hook on the locking push rod center rail was visibly damaged. The damage to the push rod may have occurred with forces applied while inserting the locking push rod into the applicator housing during set up of the applicator or is known to occur if an attempt was made to remove the locking push rod. A review of the manufacturing records was performed and found that the lot was manufactured to specification. At this time, we are unable to reach a definitive conclusion as to how the vials were damaged. The forces applied to the device during set up and attempted use could have been a contributing factor. As reported, the plunger was advanced, resistance was felt and the sound of possible glass breaking was heard. 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 ifu also states "during applicator assembly, the progel? Push rod is designed to lock in to the applicator housing. Forced removal of the locking push rod from the applicator housing may result in potential damage to the applicator system or the chemistry cartridges. " this file represents the initial progel device used. An additional mdr is being submitted to represent the second progel device used. 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
[83730151]
Information as reported by the user facility: it was reported that the scrub tech was preparing the progel device for use in a thoracic case. When it was filled with 2ml of sterile water, the plunger was advanced, and resistance was felt and the sound of possible glass breaking was heard. The progel was put aside and was not used. A second device was brought in and the same issue occurred. A third device was prepared and used without further issue to complete the case. It was reported that the operating room scrub tech has used progel in well over 50 thoracic cases and is very experienced with the device technique. There was no patient injury as a result of this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2017-00527 |
| MDR Report Key | 6820159 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-08-25 |
| Date of Report | 2017-08-25 |
| Date of Event | 2017-08-04 |
| Date Mfgr Received | 2017-08-04 |
| Device Manufacturer Date | 2017-05-31 |
| Date Added to Maude | 2017-08-25 |
| 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 | 2017-08-25 |
| Returned To Mfg | 2017-08-23 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | 170523-001 |
| Device Expiration Date | 2018-09-01 |
| 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 | 2017-08-25 |