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

Catalog Number 623728

Device Problem Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• 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: 7520715
• MDR Text Key: 108575921
• Report Number: 1416980-2018-02937
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 623728
• Device Lot Number: H84529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2018
• Initial Date FDA Received: 05/16/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: No
• 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