MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE (1110) O.L.D. 10ML CLEAR EXACTAMED; DISPENSER, LIQUID MEDICATION

Catalog Number H9381110

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the dose marking of 10ml clear exactamed syringe had disappeared after the dispenser was cleaned with warm water.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection of the photograph observed that the 5ml markings and higher were degraded.Due to the nature of the sample, no further testing could be performed.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: (1110) O.L.D. 10ML CLEAR EXACTAMED
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• MDR Report Key: 8928128
• MDR Text Key: 156119675
• Report Number: 1416980-2019-04614
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/23/2019

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: H9381110
• Device Lot Number: H83300
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1