MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-08-30 for ARTEGRAFT AG730 manufactured by Artegraft, Inc..
[53499522]
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 the returned product and packaging verified that leakage occurred based on lower volume of liquid and smeared labeling. A root cause was not able to be identified for the complaint allegation of leaking tube as the returned product was received open with the tamper-evident seal and tube shrink wrap removed. When pressure was applied to the inverted tube no leaks occurred. There is no noticeable damage to the product tube, cap, or packaging. The device history record for batch 15h214 was re-reviewed and no related nonconformances were identified; the torque machine and capper were within specifications at the time of use and visual inspections and final visual inspections by 2 independent reviewers met the requirements at the time of release. To date, no additional complaints were reported from this product batch. No complaint trends were identified for the issue of leaking tube. The complaint issue will continue to be monitored within artegraft, inc. Quality systems, quality assurance trending.
Patient Sequence No: 1, Text Type: N, H10
[53499523]
Artegraft (collagen vascular graft) lot 15h214-004 was received in the mail with a packing slip from (b)(4) (artegraft approved distributor) stating that on (b)(6) 2015 a rn went to open the tube and the seal was leaking, so didn't feel comfortable using it. It also states that the box was sealed. A second artegraft (collagen vascular graft) was utilized on the patient instead. No patient adverse events were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2247686-2016-00009 |
| MDR Report Key | 5914110 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-08-30 |
| Date of Report | 2016-08-05 |
| Date of Event | 2016-05-26 |
| Date Mfgr Received | 2016-08-05 |
| Device Manufacturer Date | 2015-10-12 |
| Date Added to Maude | 2016-08-30 |
| 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 | 2016-08-30 |
| Returned To Mfg | 2016-08-05 |
| Model Number | AG730 |
| Catalog Number | AG730 |
| Lot Number | 15H214-004 |
| Device Expiration Date | 2018-08-31 |
| Operator | NURSE |
| 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 | 2016-08-30 |