MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE; SYRINGE WITH NEEDLE

Catalog Number	309632
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the scale markings of a bd syringe with bd precisionglide¿ needle were missing, found before use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: two open shelf cartons of sealed 5ml packaged syringes with needles were received by bd canaan and confirmed to be from batch #7264700 (p/n 309632).The samples were visually evaluated.Some of the syringes were found to have missing print in the center of the scale.Most of the syringes were completely blank.The missing print observed was rejectable per product specification.Dhr review for batch 7264700 (p/n 309632): manufacturing date: 9/22/2017 to 9/23/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7264700 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the sample evaluation bd canaan was able to confirm the customer's indicated failure.Based on the severity assigned to this complaint and the results of the complaint lot history check, capa is not required at this time.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7221400
• Report Number: 1213809-2018-00009
• Device Sequence Number: 854038
• Product Code: FMF
• UDI-Device Identifier: 30382903096320
• UDI-Public: 30382903096320
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2018

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: 08/31/2022
• Device Catalogue Number: 309632
• Device Lot Number: 7264700
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 01/03/2018
• Initial Report FDA Received Date: 01/26/2018
• Supplement Report FDA Received Date: 03/16/2018
• 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