MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-610
Medical Device Problem Code	Contamination of Device Ingredient or Reagent (2901)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: is best approximation.
Event or Problem Description
During an internal inspection, a hair was found inside the package across the sealing area.
Additional Manufacturer Narrative
From the root cause investigation, it indicated that there was a production process operators' error or raw material's defect - not detected during visual inspection.The reference stock was inspected, and the present issue has only been seen in the present case.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8691078
• Report Number: 3002807968-2019-00025
• Device Sequence Number: 16645664
• Product Code: JKA
• UDI-Device Identifier: 05700699566102
• UDI-Public: (01)05700699566102(17)210305(10)HE51
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2019

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: Other
• Device Expiration Date: 03/05/2021
• Device Model Number: 956-610
• Device Catalogue Number: 956-610
• Device Lot Number: HE-51
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1