MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 20 ML EXACTA-MED DISP,CLEAR; DISPENSER, LIQUID MEDICATION

Catalog Number 11000296

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the calibration marks of five (5) 20ml exactamed syringes were faded.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: upon further visual examination of the five (5) devices, the ink on the syringes appeared to be fading; however, the printing remained legible.The device malfunction does not affect the graduation/dosing marks and would not lead to an incorrect dose.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information was added to h3, h4 and h6.H4: lot manufactured during september 2020.H10: five (5) devices were received for evaluation.A visual inspection was performed which observed faded/missing print area defects on all of the syringe barrels in the same area circled in black marker by the customer.Functional testing was not performed.The reported condition was verified.The cause of the condition could not be determined.This issue is being further investigated.A batch review was conducted and a deviation was found related to the scale printing issue during the manufacture of this lot; the impacted units were discarded.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 20 ML EXACTA-MED DISP,CLEAR
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10835374
• MDR Text Key: 216094935
• Report Number: 1416980-2020-07086
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): Y
• 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,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11000296
• Device Lot Number: H89545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 02/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1