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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 15G ADJ TRAY, SURGICAL, NEEDLE

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CAREFUSION, INC ILLINOIS NEEDLE BONE MARROW 15G ADJ TRAY, SURGICAL, NEEDLE Back to Search Results
Catalog Number DIN1515X
Device Problems Tear, Rip or Hole in Device Packaging (2385); Component Misassembled (4004)
Patient Problem No Patient Involvement (2645)
Event Date 10/29/2019
Event Type  Malfunction  
Manufacturer Narrative

(b)(4) initial emdr submission. A follow up emdr will be submitted if additional information becomes available. (b)(4).

 
Event Description

Via email: we have recently been receiving concerns regarding the following product: carefusion illinois bone marrow aspiration intraosseous infusion needle, ref din1515x, lot 0001160301. The concern is the protective tubing covering the sharp is dislodging in the packaging, leaving the sharp exposed.

 
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Brand NameILLINOIS NEEDLE BONE MARROW 15G ADJ
Type of DeviceTRAY, SURGICAL, NEEDLE
Manufacturer (Section D)
CAREFUSION, INC
zona franca las americas
santo domingo
Manufacturer (Section G)
CAREFUSION, INC
zona franca las americas
santo domingo
Manufacturer Contact
anna wehrheim
75 n. fairview drive
vernon hills, IL 60061
8015652341
MDR Report Key9354286
MDR Text Key195406847
Report Number1423507-2019-00018
Device Sequence Number1
Product Code FSH
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK813338
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 02/04/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDIN1515X
Device LOT Number0001228801
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/17/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/21/2019 Patient Sequence Number: 1
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