MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-09-26 for ARROW HOWES CVC SECUREMENT 3303MCS-TA manufactured by Tidi Products, Llc.
[122167890]
Evaluation: 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
[122167891]
Customer reported the device did not hold. The dressing detached during a patient episode of sweating. It is unknown when the issue was discovered and no patient incident or injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182318-2018-00012 |
| MDR Report Key | 7911495 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-09-26 |
| Date of Report | 2018-09-24 |
| Date of Event | 2017-03-01 |
| Date Mfgr Received | 2018-09-24 |
| Date Added to Maude | 2018-09-26 |
| 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 ENTERPISE 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 | ARROW HOWES CVC SECUREMENT |
| Generic Name | GRIP-LOK 3303MCS-TA |
| Product Code | KMK |
| Date Received | 2018-09-26 |
| Model Number | 3303MCS-TA |
| Catalog Number | 3303MCS-TA |
| 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 | 2018-09-26 |