MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/BLUNT PLASTIC CANN; 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
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 3 ml ll w/blunt plastic can had scale marking issues.This was discovered before use.The following information was provided by the initial reporter: material no: 303346, batch no: 9084976.It was reported that the 1 ml marking it is actually 1.5 ml portion of the syringe.Verbatim: 1 ml marking it is actually 1.5 ml portion of the syringe.
Additional Manufacturer Narrative
Investigation summary: one photo was received and evaluated.The photo depicted a single loose 3ml ll syringe next to an opened blister package, confirmed to be from batch #9084976 (p/n 303346).The syringe was observed to have skewed scale with parts of its markings missing.Specifically, numbers 1/2, 1 and part of 1-1/2 were missing.Potential root cause for missing print defect is associated with a failure at the marker during the marking process.Adjustments were made when defect was found during production.Product was requalified per applicable acceptable quality limit before production resumed.It is possible that a limited number with missing print condition escaped detection during requalification activities.No corrective actions are necessary based on the defective rate identified.Batch 9084976 is considered in compliance with our product specification requirements.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that syringe 3ml ll w/blunt plastic cann had scale marking issues.This was discovered before use.The following information was provided by the initial reporter: material no: 303346 batch no: 9084976.It was reported that the 1ml marking it is actually 1.5ml portion of the syringe verbatim: 1ml marking it is actually 1.5ml portion of the syringe.

• Brand Name: SYRINGE 3ML LL W/BLUNT PLASTIC CANN
• 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: 8980897
• Report Number: 1213809-2019-00913
• Device Sequence Number: 14197263
• Product Code: FMI
• UDI-Device Identifier: 30382903033462
• UDI-Public: 30382903033462
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/20/2019

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 Expiration Date: 02/28/2024
• Device Catalogue Number: 303346
• Device Lot Number: 9084976
• 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: 09/20/2019
• 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