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

Catalog Number 309579

Device Problem Volume Accuracy Problem (1675)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2019

Event Type  malfunction  

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 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.".

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 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
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9511416
• MDR Text Key: 194149914
• Report Number: 1213809-2019-01297
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903095797
• UDI-Public: 00382903095797
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/23/2019
• Supplement Dates Manufacturer Received: 12/05/2019
• Supplement Dates FDA Received: 02/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other