DISPENSER, LIQUID MEDICATION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-20 for DISPENSER, LIQUID MEDICATION manufactured by Unk.

Event Text Entries

[131586121] On the ((b)(6) 2018) issue of acute care ismp medication safety alert newsletter, an article appeared regarding missing barcodes on certain products. Our staff had identified the following products that are missing barcodes on the outside of the immediate container: gatifloxacin 0. 5% ophthalmic solution 2. 5 ml, hitech, ndc (b)(4); moviprep kit, salix, ndc (b)(4); biafine topical emulsion 45 grams, valeant, ndc (b)(4); sodium chloride 3% inhalation solution 15 ml, mylan, ndc (b)(4); hurricaine gel 20% 1 oz, ndc (b)(4); spot endoscopic marker 5 ml, gi supply. Medication administered to or used by the patient: no; patient counselling provided: unknown; relevant materials provided: none; severity: circumstances or events have capacity to cause error. (b)(6), access number: (b)(4).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5082524
• MDR Report Key: 8191695
• Date Received: 2018-12-20
• Date of Report: 2018-12-20
• Date of Event: 2018-01-25
• Date Added to Maude: 2018-12-21
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: DISPENSER, LIQUID MEDICATION
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 2

• Brand Name: DISPENSER, LIQUID MEDICATION
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 3

• Brand Name: DISPENSER, LIQUID MEDICATION
• Generic Name: DISPENSER, LIQUID MEDICATION
• Product Code: KYX
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 4

• Brand Name: DISPENSER, SOLID MEDICATION
• Generic Name: DISPENSER, SOLID MEDICATION
• Product Code: NXB
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 5

• Brand Name: DISPENSER, SOLID MEDICATION
• Generic Name: DISPENSER, SOLID MEDICATION
• Product Code: NXB
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Device Sequence Number: 6

• Brand Name: DISPENSER, SOLID MEDICATION
• Generic Name: DISPENSER, SOLID MEDICATION
• Product Code: NXB
• Date Received: 2018-12-20
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: UNK
• Manufacturer Address: UNK UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-12-20