PROGEL PLUERAL AIR LEAK SEALANT PGPS002

MAUDE Adverse Event Report

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..

Event Text Entries

[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


MAUDE Entry Details

Report Number1213643-2017-00527
MDR Report Key6820159
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-08-25
Date of Report2017-08-25
Date of Event2017-08-04
Date Mfgr Received2017-08-04
Device Manufacturer Date2017-05-31
Date Added to Maude2017-08-25
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactANNA SMITH
Manufacturer Street100 CROSSINGS BLVD.
Manufacturer CityWARWICK RI 02886
Manufacturer CountryUS
Manufacturer Postal02886
Manufacturer Phone4018258449
Manufacturer G1NEOMEND INC -2953195
Manufacturer Street60 TECHNOLOGY DRIVE
Manufacturer CityIRVINE CA 92618
Manufacturer CountryUS
Manufacturer Postal Code92618
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROGEL PLUERAL AIR LEAK SEALANT
Generic NameSEALANT, POLYMERIZING
Product CodeNBE
Date Received2017-08-25
Returned To Mfg2017-08-23
Model NumberNA
Catalog NumberPGPS002
Lot Number170523-001
Device Expiration Date2018-09-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerDAVOL INC., SUB. C.R. BARD, INC.
Manufacturer Address100 CROSSINGS BLVD. WARWICK RI 02886 US 02886


Patients

Patient NumberTreatmentOutcomeDate
10 2017-08-25

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