MAUDE Adverse Event Report: CODAN MEDICAL OEM JERINGA 1ML META SUSP; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	090190022
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection of the photograph revealed faded ink on the syringe.The syringe showed signs of use.No functional testing was performed due to the nature of the sample.The reported condition was verified.The cause of the condition was not determined.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an oem jeringa 1ml meta susp was missing the print on the syringe.This event occurred during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: OEM JERINGA 1ML META SUSP
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): CODAN MEDICAL; rodbyhavn
• MDR Report Key: 8006778
• Report Number: 1416980-2018-06796
• Device Sequence Number: 1222103
• Product Code: NEP
• UDI-Device Identifier: 00085412480497
• UDI-Public: (01)00085412480497
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: NI
• 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
• Report Date (Section B): 10/25/2018

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 Catalogue Number: 090190022
• Device Lot Number: B301L159P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2018
• Initial Report FDA Received Date: 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1