MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB; PISTON SYRINGE

Catalog Number	305904
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced product damage/deformation with the device still considered operable.It is not specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: material no: 305904 batch no: unknown.Customer is advising they no longer use this item due to safety concerns with the product.
Additional Manufacturer Narrative
H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.
Event or Problem Description
It was reported that an unspecified number of syringe 3ml ll w/ndl sftygld 25x5/8 rb experienced product damage/deformation with the device still considered operable.It is not specified whether the product defect was noted prior to, during, or after use.The following information was provided by the initial reporter: material no: 305904, batch no: unknown.Customer is advising they no longer use this item due to safety concerns with the product.

• Brand Name: SYRINGE 3ML LL W/NDL SFTYGLD 25X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9088141
• Report Number: 1213809-2019-00950
• Device Sequence Number: 16617588
• Product Code: FMF
• UDI-Device Identifier: 30382903059042
• UDI-Public: 30382903059042
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/20/2019

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 Catalogue Number: 305904
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 09/19/2019
• Supplement Report FDA Received Date: 11/25/2019
• 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