MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. GRIPPER PLUS 22G 3/4"; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problems Contamination (1120); Device Difficult to Setup or Prepare (1487); Defective Component (2292); Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problems Anaphylactoid (2218); Swelling/ Edema (4577)

Event Date 05/29/2023

Event Type  Injury  

Event Description

Pt reports swells on (b)(6) 2023 to their left foot, stomach, tongue, & throat; benadryl & epinephrine were used to treat (doses unknown).Pt also reports hospitalization for 2 days in a row due to these swells because they did not have rescue med on hand due to berinert dose malfunction.Swell treatment while hospitalized & resolution status/dates unknown.Exact dates of hospital admittance & discharge unknown.Unknown if md aware.Unknown if events occurred on scheduled takhzyro dosing day.Pt reports 4 doses of berinert dispensed on (b)(6) 2023 malfunctioned; defective product lot number & expiration date not provided by pt.Per pharmacy dispensing system from (b)(6) 2023 berinert fill: lot number pl0051b205 & expiration date 03/30/2025.Consent to contact the patient's hcp was not asked.All known information is contained on this form.Pt.States they used 1 berinert dose on (b)(6) 2023 and 1 dose on (b)(6) 2023.2 doses total used; the other 4 doses malfunctioned & were not usable.Pt.Reports the pressure didn't go through so couldn't mix.Pt.Reports their home health had to pull the berinert out with a syringe to be able to mix med.Pt.Also reports 1 needle gripper plus 22g 3/4-inch lot number unknown has a hair in the needle & wasn't able to be used.Unknown if defective berinert or needle is available for return.Unknown if pt.Has any photos of defective products.No further info.Details or dates available.Reported to (b)(6) by: patient/caregiver.Pt name: (b)(6).Reference reports: #mw5118444, #mw5118445 and #mw5118446.

• Brand Name: GRIPPER PLUS 22G 3/4"
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 17162591
• MDR Text Key: 317564953
• Report Number: MW5118443
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: BERINERT.
• Patient Outcome(s): Hospitalization
• Patient Age: 24 YR
• Patient Sex: Female