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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG PINNACLE®; SET, I.V. FLUID TRANSFER
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B. BRAUN MELSUNGEN AG PINNACLE®; SET, I.V. FLUID TRANSFER Back to Search Results
Model Number 2112341
Device Problem Labelling, Instructions for Use or Training Problem (1318)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/14/2021
Event Type  malfunction  
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by user facility: customer reported the identification flags on lines 1 and 2 of a pinnacle 6-lead transfer set were on the wrong lines (flag 1 on line 2, flag 2 on line 1).The patient order was scrapped.
 
Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
 
Event Description
As reported by user facility: customer reported the identification flags on lines 1 and 2 of a pinnacle 6-lead transfer set were on the wrong lines (flag 1 on line 2, flag 2 on line 1).The patient order was scrapped.
 
Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Customer reported that the label was printed incorrectly, and defect was confirmed.This was deemed as a mistake in manufacturing.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
 
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Brand Name
PINNACLE®
Type of Device
SET, I.V. FLUID TRANSFER
Manufacturer (Section D)
B. BRAUN MELSUNGEN AG
carl- braun strabe 1
melsungen, 34212
GM  34212
Manufacturer (Section G)
B. BRAUN AVITUM ITALY S.P.A
via xxv luglio 11
mirandola, 41037
IT   41037
Manufacturer Contact
jonathan severino
861 marcon blvd.
allentown, PA 18109
4847197287
MDR Report Key13175402
MDR Text Key286341116
Report Number9610825-2021-00560
Device Sequence Number1
Product Code LHI
UDI-Device Identifier04046964200229
UDI-Public(01)04046964200229
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041222
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2112341
Device Catalogue Number2112341
Device Lot Number21D06
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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