FDA Adverse Event Malfunction Summary report: N

EQUISTREAM HEMODIALYSIS CATHETER

MDR report key: 8621665 · Received May 17, 2019

Report

Report Number: 3006260740-2019-01426
Event Type: Malfunction
Date Received: May 17, 2019
Report Date: May 17, 2019
Manufacturer: BARD ACCESS SYSTEMS
Product Code: MSD
UDI-DI: 00801741013690
PMA / PMN Number: K090101
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A MANUFACTURING REVIEW WILL BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. EXPIRY DATE (08/2020).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING USE OF A EQUISTREAM CATHETER, THE TIP ALLEGEDLY BROKE. THERE WAS NO REPORTED PATIENT INJURY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
414481	EQUISTREAM HEMODIALYSIS CATHETER	DIALYSIS CATHETER	MSD	BARD ACCESS SYSTEMS	5903190	RECZ3009	00801741013690

Patients

Seq	Age	Sex	Outcome	Treatment
1