MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-09-27 for EXTRA SMALL PICC AND LINE SECUREMENT 2200NUZA manufactured by Tidi Products, Llc.
[122462507]
Since the product was not returned for evaluation the reported issue could not be confirmed. This report is being submitted solely on the reported issue. If the device does not adhere as expected, catheter could become dislodged or risk of infection if there is not a good seal. 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
[122462508]
Customer reported the inside adhesive did not stick as well as the top adhesive on the fabric. As a result, the flap came off onto hub of picc line. This issue was discovered during set-up and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00010 |
| MDR Report Key | 7915632 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-09-27 |
| Date of Report | 2018-09-24 |
| Date of Event | 2016-09-30 |
| Date Mfgr Received | 2018-09-24 |
| Device Manufacturer Date | 2016-03-09 |
| 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 | EXTRA SMALL PICC AND LINE SECUREMENT |
| Generic Name | GIRP-LOK 2200 NUZA |
| Product Code | KMK |
| Date Received | 2018-09-27 |
| Model Number | 2200NUZA |
| Catalog Number | 2200NUZA |
| Lot Number | 23171906 |
| 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 |