MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-13 for ARGYLE 8888750018 manufactured by Covidien.
[67493594]
Submit date: 2/13/2017.
Patient Sequence No: 1, Text Type: N, H10
[67493595]
The customer reported that the tubing is kinked.
Patient Sequence No: 1, Text Type: D, B5
[115963985]
A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. Two samples were received for evaluation. A visual inspection was performed and a kink was found on the tubes. 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 | 2936999-2017-05001 |
| MDR Report Key | 6327141 |
| Date Received | 2017-02-13 |
| Date of Report | 2017-04-06 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-04-06 |
| Date Added to Maude | 2017-02-13 |
| 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 BLVD. INSURGENTES LIBRIAMEN A LA P, LA MESA |
| Manufacturer City | TIJUANA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ARGYLE |
| Generic Name | CATHETER (GASTRIC, COLONIC, ETC.), IRRIGATION AND ASPIRATION |
| Product Code | KDH |
| Date Received | 2017-02-13 |
| Returned To Mfg | 2017-02-20 |
| Model Number | 8888750018 |
| Catalog Number | 8888750018 |
| 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 BLVD. INSURGENTES LIBRIAMEN A LA P, LA MESA TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-13 |