MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION ORAL SYRINGE PHARMACY PACK; DISPENSER, LIQUID MEDICATION

Catalog Number H93884205

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event occurred weekly since (b)(6) 2019.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there were issues with the graduation marks of a 5ml oral syringe pharmacy pack.It was further reported that the syringe starts to wear out after a couple of uses (3 to 4 days) and then gradually gets worse.This issue was identified during use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

H10: the actual sample was received for evaluation.Unaided visual inspection was performed which observed that the syringe graduations and text on the syringe barrel were rubbed off /fading.The reported condition was verified.The cause of the reported condition was not determined.A functional testing was not performed for this complaint.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ORAL SYRINGE PHARMACY PACK
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9482574
• MDR Text Key: 171649453
• Report Number: 1416980-2019-06951
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

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: Lay User/Patient
• Device Catalogue Number: H93884205
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/17/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1