MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE; PISTON SYRINGE

Catalog Number	309579
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
Material no.309579 batch no.9114915.It was reported that before use of the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle the syringes missing scale markings.The following information was provided by the initial reporter: "received some without graduation markings on the syringes.".
Additional Manufacturer Narrative
H.6 investigation summary: nine sealed packaged 3ml syringes with needles were received, confirmed to be from batch #9114915 (p/n 309579).The samples were visually evaluated.All syringes were observed to have missing print condition with none of the scale markings printed on their barrels.No corrective actions are necessary based on the defective rate identified.Batch 9114915 is considered in compliance with our product specification requirements.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.No corrective actions are necessary based on the defective rate identified.Batch 9114915 is considered in compliance with our product specification requirements.H3 other text : see h.10.
Event or Problem Description
Material no.309579, batch no.9114915.It was reported that before use of the bd 3ml syringe luer-lok¿ tip with bd precisionglide¿ needle the syringes missing scale markings.The following information was provided by the initial reporter: "received some without graduation markings on the syringes.".

• Brand Name: BD 3ML SYRINGE LUER-LOK TIP WITH BD PRECISIONGLIDE NEEDLE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9511416
• Report Number: 1213809-2019-01297
• Device Sequence Number: 19500043
• Product Code: FMF
• UDI-Device Identifier: 00382903095797
• UDI-Public: 00382903095797
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 03/31/2024
• Device Catalogue Number: 309579
• Device Lot Number: 9114915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 02/19/2020
• 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