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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET

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BECTON DICKINSON, S.A. INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 515306
Device Problem Packaging Problem (3007)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/23/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It has been reported that one infusion adapter c100 has been found experiencing packaging problems before use. The following has been provided by the initial reporter: material no. 515306, batch no. Unknown it was reported that the paper is shedding particulate to a much greater extent compared to previous packaging. Phaseal packaging particulate per customer: my techs have noticed that the packaging has changed on the injectors and bag spikes. The paper is shedding particulate to a much greater extent compared to previous packaging or to the current protector packaging noted in particular under the hood tray.
 
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Brand NameINFUSION ADAPTER C100
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer (Section G)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8874499
MDR Text Key153948800
Report Number3003152976-2019-00514
Device Sequence Number1
Product Code ONB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K123213
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number515306
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/23/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/08/2019 Patient Sequence Number: 1
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