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

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.

• Brand Name: SYR 10ML SILICONE-FREE LUER-LOCK NORM-JECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): HENKE-SASS WOLF, GMBH
• MDR Report Key: 8206254
• MDR Text Key: 131899486
• Report Number: MW5082678
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 55555000099
• UDI-Public: 55555000099
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22 YR