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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML CITRATE 4% FILL CANADA

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML CITRATE 4% FILL CANADA Back to Search Results
Catalog Number 303270
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 09/17/2019
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that 7 syringe 3ml citrate 4% fill (b)(4) were involved in an allergic reaction after use. The following information was provided by the initial reporter: material no. : 303270 batch no. : unknown. Per complaint form: our infection control team reported to us a rise in catheter related blood stream infections in july and august. There are periods where we will see spikes in infections for various reasons. Per response email: we are unsure if these infections were related to bd citrate syringes but were enquiring to see if there has been any concerns from other dialysis units in regards to catheter related bacteremia. Reporting 7 patients over 2 months with different organisms causing their bloodstream infections. 3 with staph. Aureus, (b)(6), 2 episodes of coagulase negative s. Aureus in 1 patient, 1 case of staph lugdunensis.
 
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Brand NameSYRINGE 3ML CITRATE 4% FILL CANADA
Type of DeviceSYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key9168071
MDR Text Key195537326
Report Number1911916-2019-01061
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number303270
Device Lot NumberUNKNOWN
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 Received09/17/2019
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: 10/08/2019 Patient Sequence Number: 1
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