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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% SODIUM CHLORIDE INJECTION, U%PERCENT
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BD BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% SODIUM CHLORIDE INJECTION, U%PERCENT Back to Search Results
Device Problems Delivered as Unsterile Product (1421); Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/22/2017
Event Type  malfunction  
Event Description
Bd posiflush sf saline flush syringes 10 ml sterile packed 0.9% sodium chloride injection, have been found to show evidence of having been wet.This is a wide-spread problem that has been identified not just in one area of the hospital, but in many areas of our two-hospital system, including in sterile packs.We have reports that the same issue has been found in another hospital.In our hospital system different lot numbers are affected.We consider the product non-sterile, as per current aami / aorn guidelines.Therapy start date: (b)(6) 2017.Diagnosis or reason for use: flush ports after insertion of central line, and q8h."event abated after use stopped or dose reduced: doesn't apply, event reappeared after reintroduction: doesn't apply.".
 
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Brand Name
BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% SODIUM CHLORIDE INJECTION, U%PERCENT
Type of Device
BD POSIFLUSH SF SALINE FLUSH SYRINGE 0.9% SODIUM CHLORIDE INJECTION, U%PERCENT
Manufacturer (Section D)
BD
MDR Report Key7101317
MDR Text Key94379097
Report NumberMW5073863
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/22/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date05/31/2020
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/07/2017
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
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