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

Catalog Number 090190022

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): CODAN MEDICAL; rodbyhavn
• Manufacturer (Section G): CODAN MEDICAL; faergevej 4 rodbyhavn; rodbyhavn ; DA
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8006782
• MDR Text Key: 125127190
• Report Number: 1416980-2018-06797
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 00085412480497
• UDI-Public: (01)00085412480497
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 090190022
• Device Lot Number: B301L159P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1