MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-616
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the customer reports that nurses have had a lot of difficulties to activate the needle shield device several times.The customer failed to activate the needle shield device.They have not been able to move the security down.They said that the plastic was too hard.There are no reports of serious injury or death.
Additional Manufacturer Narrative
The documentation has been checked.There are no reports in the product journal related to the reported issue.Reference samples have been subjected to safeguard activation test, and it was found that the tested samples did not pass the test.Based on the investigation the root cause was found to be an assembly process error.The corrective/preventive action is to implement a new label on the syringe cylinder which has a positive impact on the force to release the needle shield device, meaning lower friction between label and inner tube of the needle shield device.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 11162769
• Report Number: 3002807968-2021-00001
• Device Sequence Number: 18984373
• Product Code: JKA
• UDI-Device Identifier: 05700699566164
• UDI-Public: (01)05700699566164(17)220806(10)KA50
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2021

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: 06/08/2022
• Device Model Number: 956-616
• Device Catalogue Number: 956-616
• Device Lot Number: KA-50
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/29/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 01/13/2021
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1