FDA Adverse Event Malfunction Summary report: N

GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

MDR report key: 3831915 · Received March 6, 2014

Report

Report Number: 3006260740-2014-00099
Event Type: Malfunction
Date Received: March 6, 2014
Date of Event: February 10, 2014
Report Date: February 11, 2014
Manufacturer: C.R. BARD, INC. (BASD)
Product Code: LJS
PMA / PMN Number: K034020
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE COMPLAINT OF A LEAK WAS CONFIRMED, BUT THE EXACT CAUSE WAS UNKNOWN. THE PRODUCT RETURNED FOR EVALUATION WAS A 4FR S/L GROSHONG NXT CLEARVUE PICC. THE SAMPLE WAS HEAVILY OCCLUDED WITH A WHITE RESIDUE. CLOSE EXAMINATION OF THE 35CM DEPTH MARKING AREA REVEALED A PINHOLE IN THE CATHETER. MICROSCOPIC EXAMINATION OF THE PINHOLE SHOWED THAT THE FRACTURE SITE HAD SHARPLY DEFINED EDGES, AND THE DAMAGE GRADUATED FROM THE EXTERIOR TO INTERIOR CATHETER SURFACES. THE DAMAGE WAS CAUSED BY A SHARP INSTRUMENT EXTERNAL TO THE CATHETER, AND LIKELY OCCURRED PRIOR TO INSERTION, BUT THE TIMING AND SOURCE OF THIS DAMAGE WAS UNDETERMINED. A LOT HISTORY REVIEW (LHR) OF REVE0112 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PICC WAS INSERTED INTO PATIENT ON (B)(6) 2013. THE PROCESS WENT SMOOTHLY. ON (B)(6), WHEN THE PATIENT WENT BACK TO THE HOSPITAL FOR REGULAR MAINTENANCE, SHE FOUND THE CATHETER WAS LEAKING. SO SHE PULLED OUT THE CATHETER AND FIGURED OUT THERE WAS A SUBCUTANEOUS LEAKAGE AT THE SITE OF 35CM. SO SHE CHANGED ANOTHER SET OF PICC FOR THE FURTHER THERMOTHERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
136009	GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY	LJS	LJS	C.R. BARD, INC. (BASD)	NA	REVE0112

Patients

Seq	Age	Sex	Outcome	Treatment
1	56 YR		Required Intervention