MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW; PISTON SYRINGE

Model Number	305274
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that an unspecified number of syringe integra 3ml w/ndl 21x1-1/2 rb tw experienced difficult plunger movement during use.The following information was provided by the initial reporter: depot injection drew up fine into needle, on administration the plunger moved quickly, depot medication evident on glove of administrator and syringe would move no further than 0.5ml.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 21X1-1/2 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9639153
• Report Number: 1213809-2020-00021
• Device Sequence Number: 16338212
• Product Code: MEG
• UDI-Device Identifier: 30382903052746
• UDI-Public: 30382903052746
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 305274
• Device Catalogue Number: 305274
• Device Lot Number: 7177705
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 02/04/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown