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 2017-05-11 for ARGYLE 8888750018 manufactured by Covidien.
[74916816]
Submit date: 5/11/2017. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[74916817]
The customer reported that the gastric tube was bent/crimped.
Patient Sequence No: 1, Text Type: D, B5
[115815284]
Seven samples were received for evaluation. A visual inspection was performed and the tubing was found kinked. The reported issue was confirmed. An investigation of the manufacturing process was performed. It was found that the process consists of taking the tube and system and the operator connects them together. The product is then packaged and then placed in a box. The issue was found to not be manufacturing related. However, pieces of tape were found on the tubing samples. A possible root cause can be due to the outside supplier? S packaging process. A formal corrective and preventative action was implemented as a result. 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
[115815285]
The customer reported bent/crimping of the edlich gastric lavage tube.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2936999-2017-05200 |
| MDR Report Key | 6559821 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-05-11 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-04-24 |
| Date Mfgr Received | 2017-05-12 |
| Date Added to Maude | 2017-05-11 |
| 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 A LA P, LA MESA |
| Manufacturer City | TIJUANA 22225 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 22225 |
| 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 | 2017-05-11 |
| Returned To Mfg | 2017-05-12 |
| Model Number | 8888750018 |
| Catalog Number | 8888750018 |
| Lot Number | 170270267 |
| 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 A LA P, LA MESA TIJUANA 22225 MX 22225 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-11 |