MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION (62.1805) O.L.D. 1ML CLEAR EXACTAMED; DISPENSER, LIQUID MEDICATION

Catalog Number 621805

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date and month of year 2020.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the calibration marks of o.L.D.1ml clear exactamed fades out very easily.This was identified during unspecified process step.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which observed a faded printing at the middle graduation section of the syringe.The reported condition was verified.The cause of the condition is manufacturing related.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: (62.1805) O.L.D. 1ML CLEAR EXACTAMED
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10685819
• MDR Text Key: 211633612
• Report Number: 1416980-2020-06432
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): Y
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 621805
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1