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

Catalog Number	309632
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/04/2017
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, a supplemental report will be filed.
Event or Problem Description
It was reported that the scale markings on a bd syringe with bd precisionglide¿ needle were not marked before use.No injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: sample evaluation: forty-nine 5ml syringes were received by bd canaan and confirmed to be from batch #7264700 (p/n 309632).The samples were visually evaluated.Forty one (41) of the syringes were packaged, 8 syringes were received loose.Out of these: 34 syringes were completely blank, while 15 syringes had some print near the barrel flange and barrel collar ends.Dhr review for batch 7264700 (p/n 309632): manufacturing dates: 09/22/2017 to 09/23/2017.Batch quantity was (b)(4).Printer and assembly records were reviewed as part of this dhr review.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: ¿ confirmed: bd canaan was able to confirm the customer's indicated failure.Investigation conclusion: root cause undetermined.

• Brand Name: BD SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Common Device Name: SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 7148155
• Report Number: 1213809-2017-00384
• Device Sequence Number: 158592
• Product Code: MEG
• 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,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2018

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 03/12/2018
• 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