MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-31 for COLLECTION SET TUBING PVC (10/PK) 23116 manufactured by Seisa Medical Sales, Llc.
[146941659]
The device was returned to the service center for evaluation. A visual inspection was performed on the returned device and found the disposable collection set sealed in its original packaging with a long hair inside. In addition, the original equipment manufacturer (oem) reviewed the 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 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 that the gowning procedure will be revised to implement turning the gown inside out prior to placing it on the hanger when leaving the clean room, in order to eliminate the possibilities of hair on the product.
Patient Sequence No: 1, Text Type: N, H10
[146941660]
The service center was informed that during a therapeutic dilation and curettage (d&c) procedure, the user noted a hair inside the sterile packaging. The device was replaced and the intended procedure was completed. There was no patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-00896 |
| MDR Report Key | 8660792 |
| Date Received | 2019-05-31 |
| Date of Report | 2019-05-31 |
| Date of Event | 2019-02-19 |
| Date Mfgr Received | 2019-02-19 |
| 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 |
| 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 | 0 |
| Brand Name | COLLECTION SET TUBING PVC (10/PK) |
| Generic Name | COLLECTION SET TUBING PVC |
| Product Code | HHK |
| Date Received | 2019-05-31 |
| Returned To Mfg | 2019-04-17 |
| Model Number | 23116 |
| Lot Number | S188620 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |