FDA Adverse Event Malfunction Summary report: N

LACRICATH LACRIMAL DUCT CATHETERS

MDR report key: 4243189 · Received November 11, 2014

Report

Report Number: 1649914-2014-00056
Event Type: Malfunction
Date Received: November 11, 2014
Date of Event: October 21, 2014
Report Date: October 21, 2014
Manufacturer: QUEST MEDICAL, INC.
Product Code: OKS
PMA / PMN Number: K113867
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

QUEST MEDICAL, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. QUEST MEDICAL, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

AN OPHTHALMOLOGIST APPROACHED THE MANUFACTURER DURING A TRADE SHOW AND MENTIONED AN ISSUE WITH THE LACRICATH CATHETERS THAT HE HAS ENCOUNTERED DURING SURGERY. THE PHYSICIAN REPORTED THAT ON MORE THAN ONE OCCASION (NUMBER NOT SPECIFIED) DURING USE THE HYPOTUBE OF THE CATHETER HAD BROKEN DURING INSERTION, WHILE BENDING THE CATHETER. THE PHYSICIAN HAD NOT NOTED THE EXACT MODEL NUMBER(S) OR LOT NUMBER(S) OF ANY OF THE SAMPLES. THE PHYSICIAN REPORTED THAT HE WOULD OPEN ANOTHER CATHETER AND COMPLETE THE PROCEDURE SUCCESSFULLY. FOLLOW UP WITH THE PHYSICIAN FOUND HE DID NOT RECALL ANY OF THE PATIENTS' AGES, GENDER, OR OTHER IDENTIFYING INFORMATION OTHER THAN IN ONE INSTANCE THE PATIENT DID HAVE A "HEAVY BROW." THE DEVICES WERE DISCARDED AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
725202	LACRICATH LACRIMAL DUCT CATHETERS	LACRIMAL STENTS AND INTUBATION SETS	OKS	QUEST MEDICAL, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention