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 2017-07-31 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..

Event Text Entries

[81437767] The subject product was returned for evaluation and visually inspected. The outer carton has an indent/creasing as found during review. Received inside of the outer carton was an unopened product applicator kit blister tray and the chemistry kit blister tray. No damage was found to the chemistry kit inner blister tray. The chemistry kit was received with the tyvek lid peeled open. The albumin glass cartridge inside was broken and the peg glass cartridge remained intact. The product outer carton was damaged but when this damage occurred cannot be determined. At this time, we are unable to reach a definitive conclusion as to how and when the vial became damaged. A review of the manufacturing records was performed and found that the lot was manufactured to specification. 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. This file represents the first progel device used. Two additional mdr's are being submitted to represent the additional progel devices 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


[81437768] As reported by the user facility: it was reported that in preparation for a case, three progel cartons were opened for use and all three albumin glass cartridges were found broken in the chemistry kits. A fourth unit was used in the case with no issues reported. It was reported that there was no damage noted to the outer cartons. The progel kits had been placed in the refrigerator for storage and at that time there was no damage identified. The refrigerator is well above freezing and the product was not frozen while in inventory.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1213643-2017-00476
MDR Report Key6754971
Report SourceCOMPANY REPRESENTATIVE,USER F
Date Received2017-07-31
Date of Report2017-07-31
Date of Event2017-06-30
Date Mfgr Received2017-07-05
Device Manufacturer Date2017-06-12
Date Added to Maude2017-07-31
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 Received2017-07-31
Returned To Mfg2017-07-11
Model NumberNA
Catalog NumberPGPS002
Lot Number170607-001
Device Expiration Date2018-01-09
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 2017-07-31

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