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

Catalog Number	309571
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2019
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 the syringe 3ml ll w/ndl 23x1 rb experienced a cracked barrel and leakage.The original report stated, "office manager said they use these syringes all the time and this most recent time on three different patients they were performing b12 shots when the syringes would crack resulting in the medicine spilling out onto the floor and not being injected into patient.All patients are fine and no medical attention required.This happened within the last few weeks.All from the same lot number.¿.
Additional Manufacturer Narrative
H.6.Investigation: 40 sealed packaged 3ml syringes with needles were received, confirmed to be from batch #8334805 (p/n 309571).All samples were visually evaluated for the reported defect.No cracked barrels or other defects were found in the returned samples.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.
Event or Problem Description
It was reported that the syringe 3ml ll w/ndl 23x1 rb experienced a cracked barrel and leakage.The original report stated, "office manager said they use these syringes all the time and this most recent time on three different patients they were performing b12 shots when the syringes would crack resulting in the medicine spilling out onto the floor and not being injected into patient.All patients are fine and no medical attention required.This happened within the last few weeks.All from the same lot number.¿.

• Brand Name: SYRINGE 3ML LL W/NDL 23X1 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8403771
• Report Number: 1213809-2019-00310
• Device Sequence Number: 16590653
• Product Code: FMF
• UDI-Device Identifier: 30382903095712
• UDI-Public: 30382903095712
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2019

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: 11/30/2023
• Device Catalogue Number: 309571
• Device Lot Number: 8334805
• Initial Date Received by Manufacturer: 02/20/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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
• Patient Age: 51 YR