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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH

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SYRINGE 10ML REG PR SALINE 10ML FILL SALINE, VASCULAR ACCESS FLUSH Back to Search Results
Model Number 306546
Device Problems Difficult to Flush (1251); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Therefore, bd corporate headquarters in (b)(4) has been listed in and the (b)(4) fda registration number has been used for the manufacture report number. Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: as neither a lot number nor a sample was available for this incident, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported syringe 10ml reg pr saline 10ml fill experienced leakage, the plunger was difficult to move, and the plunger was loose. The following information was provided by the initial reporter: "difficulty with flushes flushes to long for women's hands some syringes are hard to flush saline came out past the plunger when attempting to flush plunger comes out when trying draw blood. ".
 
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Brand NameSYRINGE 10ML REG PR SALINE 10ML FILL
Type of DeviceSALINE, VASCULAR ACCESS FLUSH
MDR Report Key12346050
MDR Text Key272988253
Report Number2243072-2021-02121
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 08/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number306546
Device Catalogue Number306546
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
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

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