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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HENKE-SASS WOLF, GMBH SYR 10ML SILICONE-FREE LUER-LOCK NORM-JECT SYRINGE, PISTON

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HENKE-SASS WOLF, GMBH SYR 10ML SILICONE-FREE LUER-LOCK NORM-JECT SYRINGE, PISTON Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 12/21/2018
Event Type  Injury  
Event Description
Patient reports that when using these syringes to administer haegarda,when she pushes the plunger down, medication does come out of the needle, as it should, but also seeps out from around the plunger. Dates of use: (b)(6) 2018 - present. Is the product compounded? no. Is the product over-the counter? no.
 
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Brand NameSYR 10ML SILICONE-FREE LUER-LOCK NORM-JECT
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
HENKE-SASS WOLF, GMBH
MDR Report Key8206254
MDR Text Key131899486
Report NumberMW5082678
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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