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 2017-03-03 for ARGYLE 5558301726 manufactured by Covidien.
[69108149]
Submit date: 3/3/2017. An investigation is currently under way; upon completion the results will be forwarded. 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
[69108150]
The customer reports that the suction tubing in our custom packs is collapsing together during surgery causing a occlusion. The staff is of the opinion that the problem may be the soft material it is made of. ? The defective items are in our custom packs not on the self as single items. I have no way of knowing how many are in the packs. We have had the packs for a while now and this is a new development. Also i do not know how many are in the packs at the warehouse. I will retrieve one and return it for you so please send me a shipping label. The products were used on cases. There were no delays to surgery. The suction tubing? S were simply replaced with the separate tubing we keep on the shelf. Surgery was completed without incident.?
Patient Sequence No: 1, Text Type: D, B5
[114498393]
Corrected information: sex.. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612030-2017-05016 |
| MDR Report Key | 6377946 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2017-03-03 |
| Date of Report | 2017-02-07 |
| Date of Event | 2017-02-07 |
| Date Mfgr Received | 2017-02-07 |
| Date Added to Maude | 2017-03-03 |
| 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 | 2017-03-03 |
| Model Number | 5558301726 |
| Catalog Number | 5558301726 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2017-03-03 |