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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
Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/04/2019
Event Type  malfunction  
Event 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
Type of Device
SET, I.V, FLUID TRANSFER
Manufacturer (Section D)
B. BRAUN MEDICAL INC.
bethlehem PA 18018
MDR Report Key8748719
MDR Text Key149788802
Report NumberMW5087700
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 06/26/2019
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received06/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Lot NumberJ8N685
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age63 YR
Patient Weight86
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