MAUDE Adverse Event Report: RMS MEDICAL PRODUCTS HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS; SUBCUTANEOUS NEEDLE SET

Model Number RMS12609

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Rash (2033); Reaction, Injection Site (2442)

Event Type  Injury  

Event Description

Patient was infusing dilaudid subcutaneous infusion for a few months.Initially, the patient was experiencing some redness during the infusion.Now the redness has turned to blisters.The clinical coordinator does not believe this incident is related to faulty product but to an allergic reaction.The patients blisters did become infected and required treatment with antibiotics.

• Brand Name: HIGH-FLO SUBCUTANEOUS SAFETY NEEDLE SETS
• Type of Device: SUBCUTANEOUS NEEDLE SET
• Manufacturer (Section D): RMS MEDICAL PRODUCTS; 24 carpenter road; chester NY 10918
• Manufacturer (Section G): RMS MEDICAL PRODUCTS; 24 carpenter road; chester NY 10918
• Manufacturer Contact: fred ma ; 24 carpenter road; chester, NY 10918 ; 8454692042
• MDR Report Key: 7886863
• MDR Text Key: 120691140
• Report Number: 1318360-2018-00003
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162613
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2019
• Device Model Number: RMS12609
• Device Lot Number: 7.191/16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other