MAUDE Adverse Event Report: CODAN MEDICAL; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	623728
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the syringe body length of five (5) 3ml dispensers were not the standard body length for the device.The syringes that were out of specification were identified before patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The actual samples were not available; however, a photograph of one sample was provided for evaluation.Analysis of the photograph could not identify whether the syringe was shorter than expected.The reported condition could not be verified for the sample with the photograph.The remaining four (4) samples were not received for evaluation; therefore, a device analysis could not be performed.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.

• Brand Name: NI
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): CODAN MEDICAL; rodbyhavn
• MDR Report Key: 7520715
• Report Number: 1416980-2018-02937
• Device Sequence Number: 1064208
• Product Code: NEP
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 07/19/2018

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: 623728
• Device Lot Number: H84529
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 05/16/2018
• Supplement Report FDA Received Date: 07/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1