RENALIN PR TEST SYSTEM PACKET

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-18 for RENALIN PR TEST SYSTEM PACKET manufactured by Minntech/medivator.

Event Text Entries

[73517685] The lot number and expiration date of renalin pr test system packet on the outer bag is not consistent with the lot number and expiration of the vial. Example 1: lot # and expiration on bag = 789574, 04/2017- lot # and expiration in vials = 796464; 06/2017 (vial 1), 793681, 05/2017 (vial 2) products were not opened or used example 2: lot # and expiration on bag = 790182; 04/2017- lot # and expiration in vials = 789573; 05/2017 (vial 1), 787110; 04/2017 (vial 2). Renalin pr test system packet products were not opened or used.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5069232
• MDR Report Key: 6510741
• Date Received: 2017-04-18
• Date of Report: 2017-04-18
• Date of Event: 2017-04-18
• Date Added to Maude: 2017-04-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: RENALIN PR TEST SYSTEM PACKET
• Generic Name: RENALIN PR TEST SYSTEM PACKET
• Product Code: LIF
• Date Received: 2017-04-18
• Lot Number: 789573
• Device Expiration Date: 2017-05-01
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: MINNTECH/MEDIVATOR

Device Sequence Number: 2

• Brand Name: RENALIN PR TEST SYSTEM PACKET
• Generic Name: RENALIN PR TEST SYSTEM PACKET
• Product Code: LIF
• Date Received: 2017-04-18
• Lot Number: 787110
• Device Expiration Date: 2017-04-01
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: MINNTECH/MEDIVATOR

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-04-18