BARDIA 30CC SILICONE-COATED LATEX FOLEY CATHETER

Report

• Report Number: 1018233-2015-00537
• Event Type: Injury
• Date Received: December 7, 2015
• Report Date: November 12, 2015
• Manufacturer: BARD SDN. BHD. -8040607
• Product Code: EZC
• PMA / PMN Number: K910846
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLE WAS RETURNED TO EVALUATION. THE LOT NUMBER IS UNKNOWN, THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "CAUTION STATE "THIS PRODUCT CONTAIN NATURAL RUBBER LATEX WHICH MAU CAUSE ALLERGIC REACTIONS." THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT ALLEGEDLY DEVELOPED A BACTERIAL INFECTION FROM THE CATHETER. THE PATIENT WENT TO HIS PHYSICIAN WHICH PRESCRIBED THE ANTIBIOTIC CIPROFLOXIN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
800726	BARDIA 30CC SILICONE-COATED LATEX FOLEY CATHETER	FOLEY CATHETER	EZC	BARD SDN. BHD. -8040607		UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention

Terms

Patient problem · 1

• Bacterial Infection

Product problems · 1

• Patient-Device Incompatibility

Source type · 2

• CONSUMER
• OTHER