MAUDE Adverse Event Report: BAXTER HEALTHCARE ¿ ROUND LAKE (1602) O.L.D. 3ML AMBER EXACTAMED; DISPENSER, LIQUID MEDICATION

Catalog Number H9381602

Device Problem Missing Information (4053)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event was observed on an unspecified date of (b)(6) 2019.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a 3 ml amber exactamed device had "numbers" that were deleted.The reporter stated that the filler was based on medium chain triglyceride oil.This was identified during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

Additional information :the pictured device is a non baxter product; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: (1602) O.L.D. 3ML AMBER EXACTAMED
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): BAXTER HEALTHCARE ¿ ROUND LAKE; round lake IL
• Manufacturer (Section G): BAXTER HEALTHCARE ¿ ROUND LAKE; 125212 w. illinois route 120; round lake IL 60073
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8917758
• MDR Text Key: 155230765
• Report Number: 1416980-2019-04559
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: H9381602
• Device Lot Number: H81048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1