FDA Adverse Event Malfunction Summary report: N

ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE

MDR report key: 36337 · Received August 29, 1996

Report

Report Number: 1314426-1996-00002
Event Type: Malfunction
Date Received: August 29, 1996
Date of Event: July 29, 1996
Report Date: August 5, 1996
Manufacturer: SHERWOOD DAVIS AND GECK
Product Code: KNT
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE CODE 2203=NO CODE GIVEN FOR MISSING EYES. 510K = K880850, K830710. PLEASE NOTE THAT THIS REPORT MAY BE BASED UPON INFORMATION NOT YET VERIFIED BY CO TO BE COMPLETE AND ACCURATE. FURTHERMORE, THIS REPORT DOES NOT NECESSARILY REFLECT A CONCLUSION OR ADMISSION BY THAT ONE OF ITS PRODUCTS HAS CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT ONE OF ITS PRODUCTS HAS MALFUNCTIONED. VOLUNTARY MEDWATCH REPORT #1009727 REC'D BY CO ON 8-29-96. ACTUAL DEVICE WAS RETURNED AND EVALUATED. THE SAMPLE RETURNED (UNK LOT #) WAS CONFIRMED TO THE MISSING DRAINAGE EYES. SAMPLES OF THE CUSTOMER'S INVENTORY (LOT 453748) WERE ALL FOUND TO HAVE DRAINAGE EYES. A REVIEW OF THE LOT HISTORY FOR THE IDENTIFIED LOT, FOUND NO DEFECTS DURING PRODUCT INSPECTION AND NO OTHER COMPLAINTS HAVE BEEN REGISTERED AGAINST THAT LOT. MFG FEELS THIS DEFECT IS AN ISOLATED EVENT, DUE TO OPERATOR ERROR. THE RETURNED SAMPLE WAS DISPLAYED AT THE PLANT FOR AWARENESS OF ALL PERSONNEL.

Description of Event or Problem · 1

DEVICE WAS PLACED IN PT BY PHYSICIAN. NURSE NOTED NO DRAINAGE. DEVICE REMOVED AND REPLACED 7/29/96. TUBE WAS NOTED TO HAVE NO EYES. PER NURSING SUPV, PT SUFFERED NO SEQUELAE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ARGYLE SALEM SUMP TUBE WITH ANTI-REFLUX VALVE	DRAINAGE TUBE	KNT	SHERWOOD DAVIS AND GECK	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Other