MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-03-15 for ARTEGRAFT AG740 manufactured by Artegraft,inc..
[70111967]
The event is deemed to be a reportable malfunction as it is uncertain whether the integrity of the sterile package may have been compromised. The investigation of returned product artegraft (collagen vascular graft) lot number 15h217-002 verified that leakage had occurred but was unable to identify a root cause for the complaint allegation of leaking tube as the returned product was received open. When pressure was applied to the upside down tube no leaks occurred. There was no noticeable damage to the tube or cap. The color of the liquid in the tube should be clear but was tinted yellow and dried brown residue was observed on the tube cap, which may imply that the product was tampered with at the customer site after the shrink wrap was removed from the product tube. The device history record for batch 15h217 was re-reviewed and no related nonconformances were identified; the in-process torque capping machine was within specifications at the time of use and visual inspections and final visual inspections by 2 independent reviews met the requirements at the time of release. No confirmed complaint trends were identified for the issues of leaking tube. To date, no additional complaints were reported from this product batch. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending. Should additional information become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[70111968]
Artegraft, inc. Received an email from an authorized distributor stating, "had a customer open a graft to be implanted and some of the sterile solution had leaked out of the bottle prior to being opened. " the complaint graft (lot 15h217-002) was not utilized. The procedure was completed with another artegraft (collagen vascular graft). No patient adverse events related to this issue were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2017-00001 |
| MDR Report Key | 6406072 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-03-15 |
| Date of Report | 2017-02-14 |
| Date of Event | 2017-02-14 |
| Date Mfgr Received | 2017-02-14 |
| Device Manufacturer Date | 2015-10-14 |
| Date Added to Maude | 2017-03-15 |
| 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 | CYNTHIA SALTER |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal | 089024247 |
| Manufacturer Phone | 7324228333 |
| Manufacturer G1 | ARTEGRAFT, INC |
| Manufacturer Street | 206 NORTH CENTER DRIVE |
| Manufacturer City | NORTH BRUNSWICK NJ 089024247 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 089024247 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTEGRAFT |
| Generic Name | COLLAGEN VASCULAR GRAFT |
| Product Code | LXA |
| Date Received | 2017-03-15 |
| Returned To Mfg | 2017-03-09 |
| Model Number | AG740 |
| Catalog Number | AG740 |
| Lot Number | 15H217-002 |
| Device Expiration Date | 2018-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARTEGRAFT,INC. |
| Manufacturer Address | 206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 089024247 US 089024247 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-15 |