FDA Adverse Event Injury Summary report: N

FORCEPS

MDR report key: 8504 · Received January 24, 1994

Report

Report Number: 1713683-1993-00008
Event Type: Injury
Date Received: January 24, 1994
Date of Event: October 13, 1993
Report Date: November 12, 1993
Manufacturer: MILTEX INSTRUMENT CO., INC.
Product Code: HTD
Adverse Event: Yes
Report Source: Distributor report
Reporter Location: CA, US
Reporter Occupation: UNKNOWN

Narratives

Description of Event or Problem · 1

AAT THE INITIATION OF A DIALYSIS TREATMENT WITH VENOUS AAIRWAAAY LINE OF DIALYSIS BLOOD TUBING SET WAS CLAMPED ONCE WITH FORCEPS. THE FACILITY NURSE OBSEERVED BLOOD BACKING UP INTO THE HEPAAARIN LINE OF THE BLOOD DTUBING SET. THE FORCEPS HAD CUT THE VENOUS AIRRWAAY LINAE RESULTING IN A ESTIMATED PT BLOOD LOSS OF 100CC. THE PT WAS GIVEN FLUID.INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FORCEPS	FORCEPS,5 1/2", DALE TUBE	HTD	MILTEX INSTRUMENT CO., INC.		UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK		Required Intervention