MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-16 for COLLECTION SET TUBING PVC (10/PK) 23116 manufactured by Seisa Medical Sales, Llc.
[142357530]
The device was not returned to olympus for evaluation; however, a photographic image of the sterile packaging was provided by the user facility. The image illustrated the pvc tubing and a foreign material remained inside the packaging. Since the pvc tubing and its sterile packaging were not returned the foreign material cannot be confirmed as organic. If the device is returned to olympus for evaluation at a later date, this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[142357531]
Olympus was informed that during setup of the procedure, the unopened package of the sterile device was noted to have some debris inside. The package remains sealed. There was no patient involvement; therefore, no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00744 |
| MDR Report Key | 8521114 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-16 |
| Date of Report | 2019-07-25 |
| Date Mfgr Received | 2019-06-26 |
| Date Added to Maude | 2019-04-16 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLECTION SET TUBING PVC (10/PK) |
| Generic Name | TUBING SET |
| Product Code | HHI |
| Date Received | 2019-04-16 |
| Returned To Mfg | 2019-04-18 |
| Model Number | 23116 |
| Lot Number | S181605 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SEISA MEDICAL SALES, LLC |
| Manufacturer Address | 9005 MONTANA AVENUE EL PASO TX 79925 US 79925 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-16 |