FDA Adverse Event Malfunction Summary report: N

ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE

MDR report key: 7586222 · Received June 11, 2018

Report

Report Number: 2648988-2018-00026
Event Type: Malfunction
Date Received: June 11, 2018
Date of Event: April 11, 2018
Report Date: May 21, 2018
Manufacturer: INTEGRA NEUROSCIENCES PR
Product Code: JXG
PMA / PMN Number: K042825
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR LOT 1173478 WAS REVIEWED AND NO ANOMALY WAS OBSERVED THAT COULD HAVE CAUSED THE REPORTED CONDITION. ALSO, NO EVENT WAS RECORDED FOR THE MENTIONED LOTS; THUS, THE LOTS COMPLIED WITH ALL IN-PROCESS INSPECTIONS AND TESTING REQUIREMENTS AS SPECIFIED IN THE MANUFACTURING SHOP ORDER AND RELATED PROCEDURES. DOCUMENT REVIEW DOES NOT SHOW ANY EVENT THAT COULD CAUSE THE REFERRED BREAKAGE. SINCE NO SAMPLE WAS RETURNED THE COMPLAINT COULD NOT BE CONFIRMED; DOCUMENTATION REVIEW SHOWS THAT THERE ARE CONTROLS TO PREVENT THIS TYPE OF DEFECT AT THE MANUFACTURING SITE; NO FURTHER EVALUATION IS POSSIBLE AT THIS MOMENT.

Additional Manufacturer Narrative · 1

IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. LINKED TO MFG REPORT NUMBER 2648988-2018-00024.

Description of Event or Problem · 1

SUS VOLUNTARY EVENT REPORT (FOI FOR MANUFACTURERS) MW5076510 WAS RECEIVED ON 21MAY2018. ON (B)(6) 2018, AN INS8401 ACCUDRAIN WITHOUT ANTI-REFLUX HAD A CRACK TO THE PROXIMAL PORT AND WAS BROKEN AT THE STOPCOCK. NO OTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
429939	ACCUDRAIN WITHOUT THE ANTI-REFLUX VALVE	N/A	JXG	INTEGRA NEUROSCIENCES PR		1173478

Patients

Seq	Age	Sex	Outcome	Treatment
1