MAUDE Adverse Event Report: COMPASS HEALTH BRANDS APEX; ORAL SYRINGE

Model Number 70004L

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Customer reported that a patient expressed concern over the dosing measurement of our syringes.When they poured the 10 ml dosage from our syringe into a graduated cylinder, they found the expected 10 ml to actually be 11 ml.Inspection results (attached): samples provided are not measuring over as indicated by customer.Samples actually are testing actually are a little under standard.2/4 samples returned are within acceptable united states pharmacopoeia/national formulary (usp/nf) standard; pass.2/4 are under the usp/nf dosing standard; fail.

• Brand Name: APEX
• Type of Device: ORAL SYRINGE
• Manufacturer (Section D): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer (Section G): COMPASS HEALTH BRANDS; 6753 engle road; middleburg heights 44130
• Manufacturer Contact: cynthia toney ; 6753 engle road; middleburg heights 44130 ; 4402682110
• MDR Report Key: 11220462
• MDR Text Key: 241240956
• Report Number: 3012316249-2021-00003
• Device Sequence Number: 1
• Product Code: KYX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 70004L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2020
• Initial Date Manufacturer Received: 09/29/2020
• Initial Date FDA Received: 01/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1