TRI-STATE PRO-PLUS ADVANTAGE TS-PRO 11C *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-05-22 for TRI-STATE PRO-PLUS ADVANTAGE TS-PRO 11C * manufactured by Tri-state Distribution.

Event Text Entries

[151085] Potential defect with the style of child-resistant safety caps used on all size vials. The vials in question are the pro-plus advantage prescription vials. There have been 3 instances of small children opening these vials. Two required visits to a local er for blood levels and observation. The other required overnight hospitalization for observation. The children ranged from 8 mos - 3 yrs of age. The medications involved included amitriptyline, nortriptyline, and tylenol w/codeine 30 mg (eg) tabs. All had potential for serious harm or death to pts. The child-resistant caps are relatively easy to open without having to push down and twist cap. Even when cap is fastened tightly, a small child could probably open the bottle. The other issue is the outer safety ring of the cap can be separated from the inner non-safety portion of the top with relatively little effort.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1018958
• MDR Report Key: 279026
• Date Received: 2000-05-22
• Date of Report: 2000-05-15
• Date Added to Maude: 2000-05-25
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: TRI-STATE PRO-PLUS ADVANTAGE
• Generic Name: PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES)
• Product Code: LDQ
• Date Received: 2000-05-22
• Model Number: TS-PRO 11C
• Catalog Number: *
• Lot Number: *
• ID Number: 6530 NON STANDARD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 270038
• Manufacturer: TRI-STATE DISTRIBUTION
• Manufacturer Address: HC 69 BOX 398 SPENCER TN 38585 US

Device Sequence Number: 2

• Brand Name: TRI-STATE PRO-PLUS ADVANTAGE
• Generic Name: PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES)
• Product Code: LDQ
• Date Received: 2000-05-22
• Model Number: TS-PRO 16C
• Catalog Number: *
• Lot Number: *
• ID Number: 6530 NON STANDARD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 270039
• Manufacturer: TRI-STATE HOSPITAL SUPPLY CORP.
• Manufacturer Address: 301 CATRELL DR. HOWELL MI 48843 US

Device Sequence Number: 3

• Brand Name: TRI-STATE PRO-PLUS ADVANTAGE
• Generic Name: PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES)
• Product Code: LDQ
• Date Received: 2000-05-22
• Model Number: TS-PRO 30C
• Catalog Number: *
• Lot Number: *
• ID Number: 6530 NON STANDARD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 270040
• Manufacturer: TRI-STATE HOSP SUPPLY CORP.
• Manufacturer Address: 301 CATRELL DR. HOWELL MI 48843 US

Device Sequence Number: 4

• Brand Name: TRI-STATE PRO-PLUS ADVANTAGE
• Generic Name: PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES)
• Product Code: LDQ
• Date Received: 2000-05-22
• Model Number: TS-PRO 40C
• Catalog Number: *
• Lot Number: *
• ID Number: 6530 NON STANDARD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 270041
• Manufacturer: TRI-STATE HOSPITAL SUPPLY CORP.
• Manufacturer Address: 301 CATRELL DR. HOWELL MI 48843 US

Device Sequence Number: 5

• Brand Name: TRI-STATE PRO-PLUS ADVANTAGE
• Generic Name: PRESCRIPTION VIALS AND CHILD SAFETY CAPS (ALL SIZES)
• Product Code: LDQ
• Date Received: 2000-05-22
• Model Number: TS-PRO 60C
• Catalog Number: *
• Lot Number: *
• ID Number: 6530 NON STANDARD
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 270044
• Manufacturer: TRI-STATE HOSPITAL SUPPLY CORP.
• Manufacturer Address: 301 CATRELL DR. HOWELL MI 48843 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2000-05-22