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 PICC CATHETER SECUREMENT 3300MWA manufactured by Tidi Products, Llc.
[122012659]
Evaluation codes: 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. Manufacturer reference file: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[122012660]
Customer reported the product is not sealed within the allocated blister pack: it is off center and sticks out at the end. This issue was discovered before use and no incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00015 |
| MDR Report Key | 7914827 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-25 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2018-09-25 |
| Device Manufacturer Date | 2017-03-03 |
| 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 PICC CATHETER SECUREMENT |
| Generic Name | GRIP-LOK 3300MWA |
| Product Code | KMK |
| Date Received | 2018-09-27 |
| Model Number | 3300MWA |
| Catalog Number | 3300MWA |
| Lot Number | 27439033 |
| 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 |