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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. 150 ML PAB CONTAINER; SET, I.V, FLUID TRANSFER
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B. BRAUN MEDICAL INC. 150 ML PAB CONTAINER; SET, I.V, FLUID TRANSFER Back to Search Results
Lot Number J8N685
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/04/2019
Type of Reportable Event Malfunction
Event or Problem Description
Compounded sterile product was prepared in ns 100 ml partial fill in 150 ml pab container manufactured by b.Braun medical inc.This was intended to be administered to pt through appx 1.5 ml, chemolock bag spike with additive port manufactured by icu medical inc.Event occurred while final product was being administered to pt and the bag spike fell out of the bag resulting in medication spill.Bag spike was found to be loosely attached to b.Braun bag.Add'l spills have occurred using b.Braun bags and icu medical chemolock bag spikes in the past.The spike fits tightly into other bag ports and the problem is isolated to the 150 ml pab container.Fda safety report id(s)# (b)(4).
 
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Brand Name
150 ML PAB CONTAINER
Common Device Name
SET, I.V, FLUID TRANSFER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key8748719
Report NumberMW5087700
Device Sequence Number1669202
Product Code LHI
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Voluntary
Initial Reporter Occupation Pharmacist
Type of Report Initial
Report Date (Section B) 06/26/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date01/31/2020
Device Lot NumberJ8N685
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date06/28/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
Patient Age63 YR
Patient Weight86
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