MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 3 ML SYRINGE W/ BD INTERLINK¿ BLUNT PLASTIC CANNULA; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	303346
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2019
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.(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that 3 ml syringe w/ bd interlink¿ blunt plastic cannula scale marking was missing.The following information was provided by the initial reporter: material no.: 303346, batch no.: unknown.It was reported that the scale marking was incorrect missing the start of 1 scale marking.Per email: she stated that catalog 303346 had incorrect scale markings.It is missing the start of 1 scale marking on it.
Additional Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, 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.H3 other text : see h.10.
Event or Problem Description
It was reported that 3 ml syringe w/ bd interlink¿ blunt plastic cannula scale marking was missing.The following information was provided by the initial reporter: material no.: 303346 batch no.: unknown it was reported that the scale marking was incorrect missing the start of 1 scale marking.Per email: she stated that catalog 303346 had incorrect scale markings.It is missing the start of 1 scale marking on it.

• Brand Name: 3 ML SYRINGE W/ BD INTERLINK¿ BLUNT PLASTIC CANNULA
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8981004
• Report Number: 1213809-2019-00915
• Device Sequence Number: 2664985
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K974363
• 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): 09/24/2019

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: 303346
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/24/2019
• 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