FDA Adverse Event
Malfunction
Summary report: N
HIPOINT 88
MDR report key: 21915670
·
Received April 26, 2025
Report
- Report Number
- 3016522967-2025-00004
- Event Type
- Malfunction
- Date Received
- April 26, 2025
- Date of Event
- March 27, 2025
- Report Date
- April 25, 2025
- Manufacturer
- ROUTE 92 MEDICAL, INC.
- Product Code
- QJP
- PMA / PMN Number
- K201518
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
PRODUCT WAS RETURNED AND UPON REVIEW THE PLASTIC HAIRLIKE FIBERS DESCRIBED WERE NOT ABLE TO BE LOCATED, THEREFORE NO CAUSE COULD BE ATTRIBUTED. THE OTHER CATHETERS INVOLVED WERE ALSO NOT RETURNED FOR INVESTIGATIONS. NO FINDINGS INDICATED THAT THE DEVICE DID NOT MEET ITS SPECIFICATIONS PRIOR TO USE.
Description of Event or Problem · 0
AFTER USING BASE CAMP AND HIPOINT 88 THE PHYSICIAN NOTED HAIRLIKE PLASTIC STRAINS NEAR THE SKIVE. THERE WAS NO IMPACT TO THE CASE AND NO UNUSUAL FRICTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1193021 | HIPOINT 88 | PERCUTANEOUS CATHETER | QJP | ROUTE 92 MEDICAL, INC. | 24120208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | HIPOINT 88. |