MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number	956-623
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	05/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The pharmacy of toulon hospital complained that it was not possible to activate the nsd on three consecutive syringes taken from batch hd-53.The user was not able to activate the nsd with one hand.It felt like as the needle shield was sealed to the syringe.They had to use both hands to make it move.No persons were exposed to blood and no impact patient management.The person who drew the sample has been correctly trained to use our sampler.According to information from the customer the affected syringes was discarded.
Additional Manufacturer Narrative
No issue was identified during the investigation of the production documentation and a check of the reference samplers.It was not possible to examine the actual affected sampler as it was discarded by the customer.The reported issue is, however, known in the production.A capa investigation has indicated the root cause to be related to the label of the device during the manufacturing process.The following counter measures have been identified: - a new label with a modified top coat material are in the progress of being implemented.- a new cleaner has been introduced in the production.- the work instruction in the production has been updated.It is recommended for similar incidents to gently twist the cylinder within the shield before activating the needle shield.

• Brand Name: SAFEPICO
• Common Device Name: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 8635949
• Report Number: 3002807968-2019-00020
• Device Sequence Number: 16697251
• Product Code: JKA
• UDI-Device Identifier: 05700699566232
• UDI-Public: (01)05700699566232(17)210217(10)HD53
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2019

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: 02/17/2021
• Device Model Number: 956-623
• Device Catalogue Number: 956-623
• Device Lot Number: HD53
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 05/29/2019
• Initial Report FDA Received Date: 05/23/2019
• Supplement Report FDA Received Date: 06/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1