PHARMACY PACK, AMBER, 1ML, 500 H9388501

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-30 for PHARMACY PACK, AMBER, 1ML, 500 H9388501 manufactured by Baxter Healthcare ? Round Lake.

Event Text Entries

[134595602] A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10

[134595603] This report summarizes 1 malfunction events. It was reported that black particulate matter was found in an exactamed oral syringe. This was observed prior to patient use. There was no patient involvement. No additional information is available.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1416980-2019-00397
• MDR Report Key: 8291061
• Date Received: 2019-01-30
• Date of Report: 2019-01-30
• Date Mfgr Received: 2018-12-31
• Date Added to Maude: 2019-01-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Street: 1101 JETER AVENUE
• Manufacturer City: OPELIKA AL 36801
• Manufacturer Country: US
• Manufacturer Postal: 36801
• Manufacturer Phone: 2242702068
• Manufacturer G1: BAXTER HEALTHCARE
• Manufacturer Street: 25212 W. ILLINOIS ROUTE 120
• Manufacturer City: ROUND LAKE IL 60073
• Manufacturer Country: US
• Manufacturer Postal Code: 60073
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: PHARMACY PACK, AMBER, 1ML, 500
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2019-01-30
• Model Number: NA
• Catalog Number: H9388501
• Lot Number: B302M074P
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BAXTER HEALTHCARE ? ROUND LAKE
• Manufacturer Address: ROUND LAKE IL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-30