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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B.BRAUN MEDICAL INC. MINI-SPIKE IV ADDITIVE DISPENSING PIN; SET, I.V. FLUID TRANSFER
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B.BRAUN MEDICAL INC. MINI-SPIKE IV ADDITIVE DISPENSING PIN; SET, I.V. FLUID TRANSFER Back to Search Results
Model Number 412012
Device Problem Material Discolored (1170)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2021
Event Type  malfunction  
Event Description
An unopened bbraun mini-spike dispensing pin was found in pharmacy stock to have brown discoloration on/in clear cap (pin-side).Product appeared untampered with and was submitted to lead pharmacist.As part of central supply product issue process, riskmaster report is being submitted.Notification form and product will be sent to central supply for further evaluation.Manufacturer has been contacted and product complaint inquiry has been filed.No further action required from quality services.
 
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Brand Name
MINI-SPIKE IV ADDITIVE DISPENSING PIN
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
B.BRAUN MEDICAL INC.
824 12th ave
bethlehem PA 18018
MDR Report Key12364805
MDR Text Key268075990
Report Number12364805
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2021
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 Number412012
Device Catalogue Number412012
Device Lot Number0061775128
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/03/2021
Event Location Hospital
Date Report to Manufacturer08/25/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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