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 2019-05-31 for COLLECTION SET TUBING PVC (10/PK) 23116 manufactured by Seisa Medical Sales, Llc.
[146941709]
The device was returned for evaluation. The original equipment manufacturer (oem) conducted an investigation for the reported device packaging issue. A visual inspection noted the package was completely sealed and a single hair strand was found inside the packaging. In addition, the original equipment manufacturer (oem) reviewed the device history records (dhr) for the subject device and lot number and no quality issues were noted during the manufacturing process. The oem also reviewed the photo images of the received product and determined that the root cause of the reported event is likely due to employees exiting and entering the gowning room at the same time, resulting in a hair falling off an employee? S gown. The oem reported the gowning procedure will be revised to implement turning inside out the gown prior to placing it on the hanger when leaving the clean room, in order to eliminated the possibilities of hair falling onto the product. In addition, retrain all personal of the clean room regarding cleaning/sanitization, and revising work instructions to include implementation of air gun to properly clean the hose of contamination.
Patient Sequence No: 1, Text Type: N, H10
[146941710]
The manufacturer was informed that during setup and prior to opening the device packaging; the user facility inspected the package and found a hair inside the sterile packaging. There was no patient injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00898 |
| MDR Report Key | 8661006 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2019-05-31 |
| Date of Report | 2019-07-03 |
| Date Mfgr Received | 2019-06-06 |
| Date Added to Maude | 2019-05-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | COLLECTION SET TUBING |
| Product Code | HHI |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-04-26 |
| Model Number | 23116 |
| Lot Number | S189313 |
| 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 | 2019-05-31 |