MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-616
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, a customer opened sterile packaging of a safepico sampler to find what looks like a hair inside.There are no reports of serious injury.
Additional Manufacturer Narrative
From the radiometer investigation the root cause was found to be a packaging process error and overlook during visual inspection.Checking production documentation: documentation has been checked.No reports in product journal related to reported issue.Photo evaluation - conclusion: on the photo provided by the customer a visible open blister package with one hair lying inside on the paper.This indicates a packaging process error and overlook during visual inspection.Checking reference samples: reference samples checked under visual inspection.All samples within specification.No issues in reference samples observed.In component code, code 4756 has been chosen as no other code is representative.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10654346
• Report Number: 3002807968-2020-00040
• Device Sequence Number: 19619343
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)210531(10)HL57
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: HL57
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/06/2020
• Supplement Date Received by Manufacturer: 11/27/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1