MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-17 for COLLECTION SET TUBING PVC (10/PK) 23116 manufactured by Seisa Medical Sales, Llc.
[68083734]
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 that 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. Olympus followed up with the user facility to obtain additional information regarding the reported event but with no result. As part of our investigation, the oem was requested to conduct a performance investigation. If additional information is received this report will be supplemented accordingly.
Patient Sequence No: 1, Text Type: N, H10
[68083735]
The user facility reported that during or setup prior to opening the device sterile packaging; the nurse inspected the package and noted what appeared to be a hair inside the packaging. There was no patient involvement; therefore, no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[96506181]
This supplemental report is being submitted to provide the original equipment manufacture? S device evaluation results. The device was returned to the original equipment manufacturer (oem) for evaluation. The oem evaluation confirmed the reported event of? Hair inside the sealed package.? A review of the dhr was performed and no anomalies were found. The inventory of finish goods was inspected and no issues were found. The oem determined two possible root causes of the reported event, and these are the combination of material and manpower, as there was no formal documented process which specifies the cleaning method of the container assigned for connectors, and person not following appropriate rules of gowning and hygiene procedure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2951238-2017-00098 |
| MDR Report Key | 6341884 |
| Date Received | 2017-02-17 |
| Date of Report | 2017-06-19 |
| Date of Event | 2017-01-24 |
| Date Mfgr Received | 2017-06-02 |
| Date Added to Maude | 2017-02-17 |
| 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 | 408935-512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COLLECTION SET TUBING PVC (10/PK) |
| Generic Name | COLLECTION SET TUBING PVC |
| Product Code | HHI |
| Date Received | 2017-02-17 |
| Returned To Mfg | 2017-04-28 |
| Model Number | 23116 |
| Catalog Number | 23116 |
| Lot Number | S164210 |
| ID Number | UDI |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2017-02-17 |