MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 1 ML EXACTA-MED DISP,CLEAR; DISPENSER, LIQUID MEDICATION

Catalog Number 11000288

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device manufacturer postal code: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that eighty (80) units of 1 ml exacta-med disp,clear had incomplete print on the barrel of the syringes.This was identified during inspection.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H4: device manufactured on an unspecified date in july 2020 h10: forty (40) devices were received for evaluation.The other forty (40) devices were not received and therefore, could not be evaluated.A visual inspection was done on the returned devices, which observed missing print in the upper area of the 0 located at the 0.1 ml graduation printing area of all 40 samples.No functional testing was performed for this complaint.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was noted to be related to variability in the screenprinting process during the manufacturing process.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: 1 ML EXACTA-MED DISP,CLEAR
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10536474
• MDR Text Key: 207019206
• Report Number: 1416980-2020-05715
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 05413765570858
• UDI-Public: (01)05413765570858
• 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
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 11000288
• Device Lot Number: H89265
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2020
• Date Manufacturer Received: 10/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1