ARROW CATH PKGD: WEDGE 5 FR 110CM
Report
- Report Number
- 3010532612-2025-00735
- Event Type
- Malfunction
- Date Received
- August 8, 2025
- Date of Event
- July 11, 2025
- Report Date
- July 14, 2025
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DYG
- UDI-DI
- 00801902002853
- PMA / PMN Number
- K892530
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4).
(B)(4) UPON FURTHER REVIEW, IT WAS DETERMINED THAT THIS COMPLAINT WAS CREATED IN ERROR, THUS, THE INITIAL MDR SUBMITTED ON 08/08/2025 SHOULD BE RETRACTED.
IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720, 3010532612-2025-00736.
IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720 ,3010532612-2025-00736, 3010532612-2025-00735.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223898 | ARROW CATH PKGD: WEDGE 5 FR 110CM | CATHETER, FLOW DIRECTED | DYG | ARROW INTERNATIONAL LLC | 16F25E0084 | 00801902002853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |