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

Catalog Number 309575

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that before use of the bd luer-lok¿ syringe with bd precisionglide¿ needle there was a scale marking issue.

Event Description

It was reported that before use of the bd luer-lok¿ syringe with bd precisionglide¿ needle there was a scale marking issue.

Manufacturer Narrative

Investigation summary: four photos were received and evaluated.The photos depict an opened shelf carton containing multiple packaged 3ml with needle product.The product was confirmed to be from batch #6139780 (p/n 309575).Several of the syringe barrels inside the packages were observed to be blank with no visible scale markings.Some of the syringes appeared to have normal full scale markings.Furthermore, 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.Potential root cause for the missing print defect is associated with the marking process.No corrective actions are necessary based on the defective rate identified.

• Brand Name: BD LUER-LOK¿ SYRINGE WITH BD PRECISIONGLIDE¿ NEEDLE
• Type of Device: CONVENTIONAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8190711
• MDR Text Key: 131312916
• Report Number: 1213809-2018-00909
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095750
• UDI-Public: 30382903095750
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 309575
• Device Lot Number: 6139780
• Date Manufacturer Received: 12/06/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other