MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2017-03-02 for ARGYLE 8888750018 manufactured by Covidien.
[68848051]
Submit date: 3/2/2017.
Patient Sequence No: 1, Text Type: N, H10
[68848052]
The customer reports when they open the packets, the tubing is crimped and twisted.
Patient Sequence No: 1, Text Type: D, B5
[115966919]
The device history record was reviewed and indicated that the product was released accomplishing all quality standards. A sample was received for evaluation. A visual inspection was performed and a kink was found on the tube. A root cause could be due to incorrect handling during the packaging or transportation process. A quality alert was creating to make the manufacturing personnel aware of this reported issue. This complaint will be used for tracking and trending purposes. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2936999-2017-05019 |
| MDR Report Key | 6373060 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-03-02 |
| Date of Report | 2017-02-17 |
| Date of Event | 2017-02-17 |
| Date Mfgr Received | 2017-02-17 |
| Date Added to Maude | 2017-03-02 |
| 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 | EDWARD ALMEIDA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524151 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 INSURGENTES BLVD |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION |
| Product Code | KDH |
| Date Received | 2017-03-02 |
| Returned To Mfg | 2017-02-28 |
| Model Number | 8888750018 |
| Catalog Number | 8888750018 |
| Lot Number | 163440256 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 INSURGENTES BLVD TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-03-02 |