6530-L1-111-61AR 13CC PRO SERIES VIALS AND CAPS AMBER CLEAR * TS-PRO13

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-01-12 for 6530-L1-111-61AR 13CC PRO SERIES VIALS AND CAPS AMBER CLEAR * TS-PRO13 manufactured by *.

Event Text Entries

[570680] Under the consumer protection safety commission, "child-resistant" packaging is not "child-proof" packaging and "child-resistant" packaging is expected to prevent 80% to 85% of children from accessing the substance? The vials should be designed to make it significantly difficult for children under five years of age to open or obtain a toxic or harmful amount within a reasonable time. Recently, our pharmacy incurred an incident where an adolescent was able to take off the vial cap of his mother's prescription and take the wrong medication. This prompted our pharmacy to conduct an informal study on the effectiveness of the vials. The results discovered that out of 50 children ages 2-6, the average time to open the vials was 45 seconds: the parent was given the vial/cap to secure it prior to administering it to their child. A follow-up study was done at the local child development center with similar results. The mfr is currently getting our vials from tristate distributors via cardinal health as our prime vendor.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1041641
• MDR Report Key: 806246
• Date Received: 2007-01-12
• Date of Report: 2007-01-12
• Date of Event: 2006-11-20
• Date Added to Maude: 2007-01-22
• 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: PHARMACIST
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: 6530-L1-111-61AR 13CC PRO SERIES VIALS AND CAPS AMBER CLEAR
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-PRO13
• Lot Number: *
• ID Number: 300/CASE 35.27/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 793754
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 2

• Brand Name: 6530-L9-600-418R 16CC PRO SERIES VIALS AND CAPS AMBER CLEAR
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-PRO16
• Lot Number: *
• ID Number: 250/CASE $34.94/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 793761
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 3

• Brand Name: 6530-L9-600-419R 40 DRAM PRO SERIES VIALS AND CAPS AMBER
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-PRO40C
• Lot Number: *
• ID Number: 105/CASE 27.45/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 793770
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 4

• Brand Name: 6530-L9-600-421R 60 DRAM PRO SERIES VIALS AND CAPS AMBER
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-RPO60C
• Lot Number: *
• ID Number: 95/CASE $28.95/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 793775
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 5

• Brand Name: 6530-L9-600-423R 400CC PRO SERIES VIALS NO CAPS AMBER CLEAR
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-MAXI 400SB
• Lot Number: *
• ID Number: 240/CASE $110.78/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 793780
• Manufacturer: *
• Manufacturer Address: * * *

Device Sequence Number: 6

• Brand Name: 64015-4198-60 500CC PRO SERIES VIALS NO CAPS AMBER CLEAR
• Generic Name: VIAL CAP
• Product Code: NXB
• Date Received: 2007-01-12
• Model Number: *
• Catalog Number: TS-MAXI 500SB
• Lot Number: *
• ID Number: 160/CASE 106.37/CASE
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 793787
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Deathisabilit	2007-01-12