MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-10-03 for DISPOSABLE 1/2IN COLLECTION SET CASE BKT-506 manufactured by Seisa Medical Sales, Llc.
[163947691]
The customer returned 10 individually packaged bkt-506 devices and reported that 3 of 10 devices had a fluid inside the sealed, sterile, pouches. All 10 devices were inspected several times and no fluid inside any of the pouches was observed. Although, previous photo images provided by the customer appeared to show moisture in the package. All 10 packages also appeared intact and still remain sealed. The devices inside each of the sealed pouches are also intact and do not appear to be broken. The cause of the reported fluid could not be determined as no fluid was observed in the packaging during the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[163947692]
The service was informed that upon receipt the sterility of three devices were found to be compromised, as fluid was noted inside the sterile packaging. The user facility reported that there was no damage was noted on the outer packaging. The devices were not use on a patient; therefore, no patient injury was reported. This is 1 of 3 reports.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2019-01135 |
| MDR Report Key | 9151744 |
| Report Source | USER FACILITY |
| Date Received | 2019-10-03 |
| Date of Report | 2019-10-03 |
| Date of Event | 2019-09-05 |
| Date Mfgr Received | 2019-09-05 |
| Date Added to Maude | 2019-10-03 |
| 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 | 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 | DISPOSABLE 1/2IN COLLECTION SET CASE |
| Generic Name | DISPOSABLE 1/2IN COLLECTION SET |
| Product Code | HHK |
| Date Received | 2019-10-03 |
| Returned To Mfg | 2019-09-19 |
| Model Number | BKT-506 |
| Lot Number | S174615 |
| 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 | 2019-10-03 |