MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-615
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident date stated is best approximation.
Event or Problem Description
According to the complaint, the customer has experienced on several occasions that the needle shield device of the safepico70 does not lock, ultimately resulting in the needle not being safe.
Additional Manufacturer Narrative
From the root cause investigation, it showed that no issues were observed.
Additional Manufacturer Narrative
Defect samplers received and forwarded for investigation.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8677956
• Report Number: 3002807968-2019-00023
• Device Sequence Number: 2522245
• Product Code: JKA
• UDI-Device Identifier: 05700699566157
• UDI-Public: (01)05700699566157(17)201129(10)BY53
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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,Followup
• Report Date (Section B): 10/17/2019

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: No Information
• Device Expiration Date: 11/29/2020
• Device Model Number: 956-615
• Device Catalogue Number: 956-615
• Device Lot Number: BY53
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 10/07/2019
• Initial Report FDA Received Date: 06/07/2019
• Supplement Report FDA Received Date: 08/22/2019; 10/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1