MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-14 for STATLOCK ARROW ARTERIAL RETAINER, SELECT PADS 50 BOX N/A ART0423 manufactured by Bard Access Systems.
[136750391]
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of an open seal was confirmed and the cause appeared to be manufacturing related. One unit pouch for statlock stabilization device was returned for investigation. The product code and lot number on the packaging was art0423 and juctf523, respectively. The pouch contained 2 foam strips. The statlock stabilization device was missing from the pouch. The end of the pouch, opposite from the chevron seal, was open. No evidence of a seal was observed at the open end of the packaging. The manufacturing facility was notified of this complaint. A lot history review (lhr) of juctf523 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[136750392]
It was reported a shipment of arterial statlocks was received with "missing and/or opened" products from the packaging. This file represents the second device received for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00274 |
| MDR Report Key | 8341462 |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-12-04 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-06-01 |
| Date Added to Maude | 2019-02-14 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SHELLY GILBERT |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225640 |
| Manufacturer G1 | DAVOL SURGICAL INNOVATIONS -9616067 |
| Manufacturer Street | AVE. ROBERTO FIERRO #6408 PARQUE INDUSTRIAL AEROPUERTO |
| Manufacturer City | CD. JUAREZ, CHIH S.A. DE C.V. 32690 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 32690 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STATLOCK ARROW ARTERIAL RETAINER, SELECT PADS 50 BOX |
| Generic Name | DRESSING, WOUND, DRUG |
| Product Code | FOX |
| Date Received | 2019-02-14 |
| Returned To Mfg | 2018-12-17 |
| Model Number | N/A |
| Catalog Number | ART0423 |
| Lot Number | JUCTF523 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-14 |