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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL AG MINI SPIKE DISP PIN; SET, I.V. FLUID TRANSFER
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B.BRAUN MEDICAL AG MINI SPIKE DISP PIN; SET, I.V. FLUID TRANSFER Back to Search Results
Patient Problems Headache (1880); Pain (1994); Swelling/ Edema (4577)
Event Type  Injury  
Event Description
Last site change: (b)(6) 2024.Pt reports initially experiencing pain and swelling at their infusion site when it was changed, but the symptoms resolved after about 4-5 days and the site is doing well right now.Pt reports they have been experiencing migraines at least once a week (onset date unknown) and occasionally takes oxycodone prn, but they don't think it helps.Pt states their md is waiting until after their right heart catheterization (scheduled for (b)(6) 2024] results to make any further adjustments to their dose.Pt also reports that the last refill of mini spikes they received have been leaking from the end where the hole is.The number of defective spikes was not specified.Pt states their previous refills were okay.Pt is currently still using one of the leaking mini spikes.Pt did not have an interruption in therapy due or experience an adverse event due to the defective product.Registered pharmacist advises pt to hold on to the malfunctioning spike in case the manufacturer requests its return.Pt did not have the lot number or expiration date available for defective mini spikes.No further information, details or dates available.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
MINI SPIKE DISP PIN
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
B.BRAUN MEDICAL AG
MDR Report Key18839334
MDR Text Key337071930
Report NumberMW5152312
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/29/2024
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? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/04/2024
Patient Sequence Number1
Treatment
AMBRISENTAN.; REMODULIN MDV.; TADALAFIL.
Patient SexFemale
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