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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER FLUSH SYRINGE, SALINE

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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER FLUSH SYRINGE, SALINE Back to Search Results
Catalog Number 306546
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problems Tachycardia (2095); Complaint, Ill-Defined (2331)
Event Date 05/01/2016
Event Type  Injury  
Manufacturer Narrative
The exact date of event is unknown. The customer reported the event occurred in (b)(6) 2016. Device evaluation: it is unknown if a sample is available for evaluation. A supplemental report will be filed upon completion of the investigation.
 
Event Description
The customer reports receiving home infusion of ivig. On her third round of infusion in (b)(6) 2016, when the visiting nurse flushed her iv access with the suspect device, the customer experienced an alcohol taste in her mouth and an increase in heart rate. The customer went to the doctor who prescribed 50ml benadryl iv to be administered prior to infusions and an epipen to be used as needed. The customer noted that her visiting nurse used a regular syringe instead of a bd posiflush⠁nd the consumer did not have any adverse reaction.
 
Manufacturer Narrative
Section h, device evaluation: result - a sample was not returned for evaluation. There were no qns or issues associated with the reported lot 6098603. There is no documentation for any bridging, or issues affecting product. All our inspections performed while manufacturing this batch were accepted; no issues or rejections were documented. Conclusion - bd was not able to duplicate or confirm the customer¿s indicated failure mode. All inspections/testing performed from molding through the case pack were acceptable with no rejections recorded. An absolute root cause for this incident could not be determined.
 
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Brand NameBD POSIFLUSH¿ NORMAL SALINE FILLED SYRINGE, 10ML FILL IN 10ML DIAMETER
Type of DeviceFLUSH SYRINGE, SALINE
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
8015652845
MDR Report Key5827041
MDR Text Key50613930
Report Number1911916-2016-00010
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K003553
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 08/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number306546
Device Lot Number6098603
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/06/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/09/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 07/27/2016 Patient Sequence Number: 1
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