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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS 10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE PREFILLED SALINE FLUSH SYRINGE Back to Search Results
Catalog Number 306500
Device Problem Nonstandard Device (1420)
Patient Problems Fever (1858); Pneumonia (2011); Respiratory Distress (2045); Complaint, Ill-Defined (2331)
Event Date 04/08/2018
Event Type  Injury  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that a patient used a 10 ml bd¿ pre-filled normal saline syringe, in 10 ml syringe on her picc line which is used to donate stem cells to her sister and became ill with a cough, high fever, and loss of appetite on (b)(6) 2018. On (b)(6) 2018, the patient went to an urgent care where she was evaluated, diagnosed with pneumonia, and given antibiotics. Information regarding the patient sister is captured under a separate mdr report # 2134319-2018-00077. *out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium. Bd was notified by the (b)(6) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the (b)(6) identified a potential connection between reports of infection in a small number of patients caused by s. Marcescens across multiple states. Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products. To date, there is no evidence of bd flush product testing positive for this bacterium. Investigations are ongoing by (b)(6).
 
Manufacturer Narrative
Fda notified?: yes. The fda was made aware of this incident via voluntary medwatch 5077738.
 
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Brand Name10 ML BD¿ PRE-FILLED NORMAL SALINE SYRINGE, IN 10 ML SYRINGE
Type of DevicePREFILLED SALINE FLUSH SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
9630 south 54th street
franklin WI 53132
MDR Report Key7642714
MDR Text Key112495169
Report Number2134319-2018-00076
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K011982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date12/07/2020
Device Catalogue Number306500
Device Lot Number734211A
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/27/2018 Patient Sequence Number: 1
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