MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-23 for PROGEL PLUERAL AIR LEAK SEALANT PGPS002 manufactured by Davol Inc., Sub. C.r. Bard, Inc..
[133850199]
Multiple attempts to obtain the sample, however the subject product was not returned for evaluation were made. Without the subject product or additional information, a definitive conclusion as to when/how the glass vial was damaged cannot be determined. If the sample is returned or additional information is received, this file will be updated. The ifu for the progel instructs the user: if package and/or product integrity have been compromised, (i. E. , damaged package seal, or broken glass) do not use or re-sterilize the contents. A review of the manufacturing records was performed and found that the lot was manufactured to specification. A review of the subject lot found this to be the first complaint reported for the 464 units released to stock in (b)(6) 2018. Device requested, but not returned.
Patient Sequence No: 1, Text Type: N, H10
[133850200]
It was reported that one progel kit had a broken glass vial inside the kit when it was opened. The contact reported that there was no damage noted on the outer box or the outer shipping carton when it was received. The problem was noted when opened during the case. The broken glass was noted inside one of the pre-loaded cartridges. The contact confirmed that there was no loose glass in the package. This condition was found in preparation for use and not on the sterile field. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1213643-2019-00409 |
| MDR Report Key | 8270321 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-23 |
| Date of Report | 2019-02-07 |
| Date Mfgr Received | 2019-01-23 |
| Device Manufacturer Date | 2018-10-12 |
| Date Added to Maude | 2019-01-23 |
| 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 | 2019-01-23 |
| Returned To Mfg | 2019-01-23 |
| Model Number | NA |
| Catalog Number | PGPS002 |
| Lot Number | IRCX0001 |
| Device Expiration Date | 2019-11-01 |
| 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 | 2019-01-23 |