FDA Adverse Event
Malfunction
Summary report: N
L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
MDR report key: 10352364
·
Received July 31, 2020
Report
- Report Number
- 1625425-2020-00449
- Event Type
- Malfunction
- Date Received
- July 31, 2020
- Date of Event
- June 17, 2020
- Report Date
- July 31, 2020
- Manufacturer
- ARGON MEDICAL DEVICES
- Product Code
- FOZ
- UDI-DI
- 00886333209934
- PMA / PMN Number
- K091670
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF RETURNED DEVICE FOUND IT LEAKED THROUGH A CRACK IN THE LUER HUB, CONFIRMING THE COMPLAINT. THE MOLDING PARAMETERS OF THE L-CATH HUBS WERE UPDATED TO MEET MANUFACTURER'S SUGGESTED SETTINGS (FM-OP-0869 UPDATED VIA CR 00100431 ON 12/11/2019). N-2020-115 WAS INITIATED TO CONTAIN PRODUCT WITH HUBS/LUERS MOLDED BEFORE THE MOLDING PARAMETERS WERE UPDATED. CAPA, (B)(4), HAS BEEN INITIATED TO IDENTIFY THE ROOT CAUSE AND IMPLEMENT THE APPROPRIATE CORRECTIVE ACTION.
Description of Event or Problem · 1
LINE HAD BEEN INDWELLING X 17 DAYS AND WAS NOTED TO BE LEAKING AND UPON FURTHER INSPECTION A CRACKED HUB WAS IDENTIFIED. INSERTED (B)(6) - REMOVED (B)(6) ¿ LOT # 11290032.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 817458 | L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM | L-CATH PICC | FOZ | ARGON MEDICAL DEVICES | 26GA (1.9F) x 30cm | 11290032 | 00886333209934 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |