MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 3ML LL W/NDL 23X1 RB TW; PISTON SYRINGE

Catalog Number	309588
Medical Device Problem Codes	Complete Blockage (1094); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 during use the syringe would not draw medication and needle was loose in the hub and caused leakage with a bd syringe 3ml ll w/ndl 23x1 rb tw.The following information was provided by the initial reporter: it was reported that a syringe would not draw back any air or liquid.It was reported that there was a leak between syringe and needle due to loose needle connection.
Event or Problem Description
It was reported that during use the syringe would not draw medication and needle was loose in the hub and caused leakage with a bd syringe 3ml ll w/ndl 23x1 rb tw.The following information was provided by the initial reporter: it was reported that a syringe would not draw back any air or liquid.It was reported that there was a leak between syringe and needle due to loose needle connection.
Additional Manufacturer Narrative
No samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident, therefore a root cause could not be determined.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• Brand Name: BD SYRINGE 3ML LL W/NDL 23X1 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9152625
• Report Number: 1213809-2019-01000
• Device Sequence Number: 419430
• Product Code: FMF
• UDI-Device Identifier: 30382903095880
• UDI-Public: 30382903095880
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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: 04/30/2024
• Device Catalogue Number: 309588
• Device Lot Number: 9140821
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other