MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2019-02-15 for DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED 203001 manufactured by Integra Lifesciences Corp.
[139876204]
The device was not yet returned to the manufacturer for analysis. The plant investigation is in progress and a supplemental medwatch report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
[139876205]
A distributor reported on behalf of the customer that 203001 duraseal spine ous 3ml kit 1kit was opened and when the dilutent syringue was connected to the powder vial to mix the two and turned around to draw the mixture back into the syringue to use as directed, the dilutent/powder mixture leaked out of the vial and only minimal was left in the vial which was not enough to use. The date of the incident was on (b)(6) 2018. There was no patient injury reported. The event led to an increase of surgery time of about 3 hours. Additional information was received on 13feb2019 indicating that the (b)(6) year old male patient was under anesthesia when the dysfunction was observed. The hospital had to source for another duraseal as the remainder of the item was packed for another surgeon case. Patient outcome was reported as doing well.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003418325-2019-00001 |
| MDR Report Key | 8345642 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2019-02-15 |
| Date of Report | 2019-01-22 |
| Date of Event | 2018-11-20 |
| Date Mfgr Received | 2019-02-19 |
| Device Manufacturer Date | 2018-07-11 |
| Date Added to Maude | 2019-02-15 |
| 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 | USER KIMBERLY SHELLY |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DURASEAL SPINE OUS 3ML KIT 1KIT/BOX CE APPROVED |
| Generic Name | DURASEAL SPINE |
| Product Code | NQR |
| Date Received | 2019-02-15 |
| Catalog Number | 203001 |
| Lot Number | 60137689 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP |
| Manufacturer Address | 311 ENTERPRISE DRIVE 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-15 |