MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION PHARMACY PACK, AMBER, 5ML; DISPENSER, LIQUID MEDICATION

Catalog Number H9388105

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported that the graduated markings of an oral syringe pharmacy pack disappeared after use.The event occurred during testing; therefore, there was no patient involvement.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the actual device was not available; however, two (2) photographs were provided for evaluation.A visual inspection was performed to the photographs using the naked eye which revealed that no graduated markings were on the syringe barrel in the first photograph and no scuffs or damage could be observed on the barrel of the sample which was inside a plastic bag.The second photograph was of a sample which showed graduated markings on the barrel of the syringe.Based on the first photograph, the reported condition was verified.Due to the nature of the sample, no additional tests could be performed.The cause of the condition could not be determined, however, a possible cause could be a defect related to variability in the screen printing and curing 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: PHARMACY PACK, AMBER, 5ML
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - RR DONNELLEY SUPPLY CHAIN SOLUTION - SP017692; 1600 disk drive; plover WI 54467
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15554819
• MDR Text Key: 303711344
• Report Number: 1416980-2022-05346
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 00085412478166
• UDI-Public: (01)00085412478166
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H9388105
• Device Lot Number: B302R008P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/11/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1