MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-09-27 for MEDIUM UNIVERSAL SECUREMENT 3300M manufactured by Tidi Products, Llc.
[122007541]
The product was not returned for evaluation, however investigation of the issue confirmed inconsistent sealing of the pouches due to a defective motor. If the packaging of a sterile device is compromised, the device may be contaminated and if not caught before use it could be a source of infection. This report is being submitted as a result of a remediation capa to reassess product risks. No further actions will be taken. All complaints are trended and reviewed by management on a monthly basis. As part of this monthly review, any excursion above the control limits for this failure mode will be assessed, documented and acted upon as warranted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122007542]
Customer reported the product is partially sealed in the pouch. This issue was discovered before use and no incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00014 |
| MDR Report Key | 7914773 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-25 |
| Date of Event | 2017-07-17 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2016-02-10 |
| Date Added to Maude | 2018-09-27 |
| 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 | JACKIE KRIEGLSTEIN |
| Manufacturer Street | 570 ENTERPRISE DRIVE |
| Manufacturer City | NEENAH WI 54956 |
| Manufacturer Country | US |
| Manufacturer Postal | 54956 |
| Manufacturer Phone | 9207514300 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIUM UNIVERSAL SECUREMENT |
| Generic Name | GRIP-LOK 3300M |
| Product Code | KMK |
| Date Received | 2018-09-27 |
| Model Number | 3300M |
| Catalog Number | 3300M |
| Lot Number | 23171907 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TIDI PRODUCTS, LLC |
| Manufacturer Address | 570 ENTERPRISE DRIVE NEENAH WI 54956 US 54956 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-27 |