FDA Adverse Event No answer provided Summary report: N

RUSCH PAED 2W 1.5ML 100% SILICONE STR 06

MDR report key: 13548436 · Received February 17, 2022

Report

Report Number
13548436
Event Type
No answer provided
Date Received
February 17, 2022
Date of Event
January 31, 2022
Report Date
February 3, 2022
Manufacturer
TELEFLEX MEDICAL SDN. BHD.
Product Code
EZL
Report Source
User Facility report
Reporter Location
CA
Reporter Occupation
OTHER HEALTH CARE PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 0

FOLEY PLACEMENT FOR ADOLESCENT MALE. ON THE STERILE FIELD RN OPENED AN 8 FR, 10 FR UPON PLACEMENT, FOLEY'S WERE TOO LARGE AND UNABLE TO ADVANCE. RN RETRIEVED A 6 FR, RN INSERTED AND ADVANCED TO THE HUB SAW URINE OUTFLOW AND INFLATED THE BALLOON WITH 5ML OF WATER AS INDICATED ON THE FOLEY. WHEN RN PULLED BACK ON THE FOLEY, THE FOLEY COMPLETELY CAME OUT. ONCE OUT RN TESTED THE BALLOON AND WAS UNABLE TO INFLATE. RN CALLED THE RSN TO CONTACT UROLOGY. ATTENDING MD AND RESIDENT ARRIVED. THEY ASSESSED, AND INSERTED AN 8 FR FOLEY. RN EXPLAINED TO THAT AFTER INSERTED THE 6 FR, IT FELL OUT. THEY INSPECTED THE BALLOON AND PERFORMED A CYSTOSCOPY. CONSENT WAS OBTAINED VIA TELEPHONE. AN 8 FR WAS PLACED BY THE UROLOGY TEAM. NO RETAINED BALLOON FRAGMENTS ON CYSTOSCOPY. RN SEQUESTERED THE FOLEY AND PACKAGING AND GAVE IT TO SURGICAL MATERIALS A 6 FR. RUSCH PEDIATRIC FOLEY CATHETER WAS USED AND THE NURSE INFLATED THE BALLOON WITH 5 ML OF STERILE WATER INSTEAD OF 1.5 ML. THE BALLOON PROBABLY POPPED AND THAT WOULD EXPLAIN WHY IT CAME OUT AFTER BALLOON WAS INFLATED AND THE NURSE WAS NOT ABLE TO INFLATE THE BALLOON AFTER THE CATHETER CAME OUT OF THE PATIENT. (B)(4), 6 FR, EXP 08/28/2026, LOT KME21J0259. OUTCOMES UPDATE FROM CARE TEAM: THE 6 FR. FOLEY CATHETER AND IT'S PACKAGE SHOWS THAT THE BALLOON CAPACITY IS 1.5 ML STERILE WATER. JRN INDICATED THAT SHE INFLATED THE BALLOON ON THE 6 FR. FOLEY CATHETER WITH 5 ML OF STERILE WATER TO THE BALLOON AFTER SHE INSERTED IT AND ADVANCED TO THE HUB. 5 ML IS TOO MUCH FOR THIS BALLOON SIZE AND MAY HAVE POPPED WHICH EXPLAINED THAT SHE WAS NOT ABLE TO INFLATE THE BALLOON AFTER IT CAME OUT. THIS INFORMATION WAS REVIEWED WITH RN AND SHE STATED THAT SHE NEEDS TO LOOK AT THE FOLEY CATHETER AND PACKAGE MORE CAREFULLY NEXT TIME. ALSO RECOMMEND NOT TO HAVE TOO MANY DIFFERENT SIZES MIXED UP ON THE STERILE FIELD AT THE SAME TIME. THERE WAS NO HARM IN THIS EVENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
861929 RUSCH PAED 2W 1.5ML 100% SILICONE STR 06 CATHETER, RETENTION TYPE, BALLOON EZL TELEFLEX MEDICAL SDN. BHD. IPN050125 KME21J0259

Patients

Seq Age Sex Outcome Treatment
1 2920 DA Male