MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK; PISTON SYRINGE

Catalog Number 309657

Device Problem Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2023

Event Type  malfunction  

Event Description

It was reported that the bd luer-lok syinges had a scale marking issue.The following information was provided by the intiial reporter: "3ml syringes missing the measurement markings on the syringe.We have received more complaints from other sites since monday.Yesterday i heard reports from (b)(6)." (b)(6) 2023.Please provide the occurrence date.On (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, (b)(6) 2023, is there any adverse event to patient due to the incident? delayed patient care is photo available for review? see below is sample available for return? if yes, please provide your address for return label.

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

Pr 9220524¿ follow up mdr for device evaluation.One-hundred and ninety-nine samples of 3ml luer-lock syringes were received by bd.A quality engineer was able to review the samples from lot #3209797 regarding item #309657.197 samples were received in sealed packages and 2 in opened packages.All 199 samples had missing print with no scale markings at all.The condition observed is non-conforming per product specification.Potential root cause for the missing print defect is associated with the marking process.The following corrective actions will be taken: re-education of associates involved in batch manufacture to applicable procedures.Send quality alert to manufacturing plant to notify all associates.A device history record review was completed for provided batch number 3209797 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• Brand Name: BD LUER-LOK
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18253617
• MDR Text Key: 329573203
• Report Number: 1213809-2023-01375
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096573
• UDI-Public: (01)30382903096573
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309657
• Device Lot Number: 3209797
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1