FDA Adverse Event Injury Summary report: N

POWERPICC 5F SINGLE-LUMEN CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE

MDR report key: 5877521 · Received August 15, 2016

Report

Report Number: 3006260740-2016-00420
Event Type: Injury
Date Received: August 15, 2016
Date of Event: June 28, 2016
Report Date: July 28, 2016
Manufacturer: BARD ACCESS SYSTEMS
Product Code: LJS
UDI-DI: 00801741027703
PMA / PMN Number: K033389
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

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. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REAQ2482 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem · 1

AS REPORTED BY THE NURSE VIA MEDWATCH: A BARD POWER PICC 55 CM 5 FRENCH WAS PLACED VIA RIGHT CEPHALIC. THE PICC WAS TRIMMED 10 CM AND POSITIONED AT 42 CM MARK. CHEST X-RAY TAKEN ON XXXX2016 SHOWED APPROPRIATE POSITION FOR PICC TIP. A THIN METALLIC OBJECT APPROXIMATELY 3 CM AT THE LEVEL OF THE RIGHT AXILLARY VEIN WAS NOTED BY RADIOLOGY ON XXX2016. INTERVENTIONAL RADIOLOGY CONSULTED AND RETRIEVED THE FOREIGN OBJECT UNDER FLUOROSCOPY. PICTURE TAKEN OF THE OBJECT BY THE RADIOLOGIST WAS CONSISTENT WITH TIP OF STYLET USED WITH POWER PICC. FBO WAS NOT KEPT."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
527413	POWERPICC 5F SINGLE-LUMEN CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE	PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER	LJS	BARD ACCESS SYSTEMS		REAQ2482	00801741027703

Patients

Seq	Age	Sex	Outcome	Treatment
1