MAUDE Adverse Event Report: REMINGTON MEDICAL, INC. ANALYER CABLE 12 FT DISPOSABLE; CABLE TRANSDUCER AND ELECTRODE

Model Number S-101-97-12(1)

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2018

Event Type  malfunction  

Event Description

Product package with two extra pins in the packet.Pins were in the rubber covering and discovered prior to pt exposure but could have dropped into sterile field.Used in electrophysiology lab.

• Brand Name: ANALYER CABLE 12 FT DISPOSABLE
• Type of Device: CABLE TRANSDUCER AND ELECTRODE
• Manufacturer (Section D): REMINGTON MEDICAL, INC. ; alpharetta GA
• MDR Report Key: 7713996
• MDR Text Key: 115062863
• Report Number: MW5078531
• Device Sequence Number: 1
• Product Code: DSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2020
• Device Model Number: S-101-97-12(1)
• Device Lot Number: 1725718
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 84 YR