MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-06-29 for ARGYLE 8888301622 manufactured by Covidien.
[78695357]
Submit date: 6/29/17. An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[78695358]
The customer reports tip of suction tubing coming off. Molded connector is not attached to tubing.
Patient Sequence No: 1, Text Type: D, B5
[113285669]
One unused samples with lot number 710018364x was received for evaluation. After performing a visual inspection the issue was observed; the inner packaging contains a broken component. The dhr file was reviewed indicating that product was released meeting all quality standard requirements. A probable root cause of this condition is attributed to a failure in the solvent presence sensors of the extruder machine where the tube is cut to length then the tips are inserted into the tubing using this solvent. The following corrective action was established: product specification has been updated to include a checklist for inspection of the machine sensors to ensure they are in good working condition to minimize the reoccurrence of the reported condition. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05120 |
| MDR Report Key | 6676825 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-06-29 |
| Date of Report | 2018-01-09 |
| Date of Event | 2017-06-06 |
| Date Mfgr Received | 2017-06-06 |
| Device Manufacturer Date | 2017-03-11 |
| Date Added to Maude | 2017-06-29 |
| 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 | CALLE 9 SUR NO. 125 CUIDAD |
| Manufacturer City | TIJUANA,NA 92173 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 92173 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARGYLE |
| Generic Name | TUBING, NONINVASIVE |
| Product Code | GAZ |
| Date Received | 2017-06-29 |
| Model Number | 8888301622 |
| Catalog Number | 8888301622 |
| Lot Number | 705916564X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | CALLE 9 SUR NO. 125 CUIDAD TIJUANA,NA 92173 MX 92173 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-29 |