FDA Adverse Event
Injury
Summary report: N
ARTERIAL POST W LUER LOCKS DW 480
MDR report key: 38004
·
Received September 10, 1996
Report
- Report Number
- 8030665-1996-00270
- Event Type
- Injury
- Date Received
- September 10, 1996
- Report Date
- August 23, 1996
- Manufacturer
- NMC MPD
- Product Code
- FJK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ARTICLE ALLEGED: ALTHOUGH NOT DIRECTLY OBSERVED, IT WAS SPECULATED THAT HEMOLYTIC REACTIONS WERE CAUSE BY KINKED BLOODLINE WHEN UPON COMPLETION OF 4 HOURS OF DIALYSIS TREATMENT, COMPLAINT OF ABDOMINAL PAIN, VOMITING, GI BLEED PANCREATITIS WERE EXPRESSED BY PT. COMPLAINTS OF THIS NATURE WERE INVESTIGATED UNDER FIR 93015. PRODUCT #0392035 UNDER SAME COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTERIAL POST W LUER LOCKS DW 480 | * | FJK | NMC MPD | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization |