MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SYRINGE SLIP TIP; PISTON SYRINGE

Catalog Number	309647
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical 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 with the use of the bd¿ syringe slip tip there was an issue with no expiration date on the packaging.
Additional Manufacturer Narrative
Investigation summary: two photos were received and evaluated.The photos depict front and back of a single sealed 5ml blister package with syringe inside.The batch # can be seen embossed on the peel tab on the bottom web, however it is not clearly visible.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Based on the location of the batch #, it appears that this batch of product was likely manufactured before the implementation of unique device identifier when expiration date became required to be printed on all individual packages.Prior to unique device identifier implementation expiration date for this product was not required and not included as part of design.
Event or Problem Description
It was reported with the use of the bd¿ syringe slip tip there was an issue with no expiration date on the packaging.

• Brand Name: BD¿ SYRINGE SLIP TIP
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8197876
• Report Number: 1213809-2018-00897
• Device Sequence Number: 13842180
• Product Code: FMF
• UDI-Device Identifier: 00382903096473
• UDI-Public: 00382903096473
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2019

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: 309647
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 02/19/2019
• 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