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

Catalog Number 309605

Device Problem Missing Information (4053)

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

Event Date 10/05/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Other lot numbers include 3130638 and 3123961.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that the bd luer-lok syringes had peeling labels, label content was missing.The following information was provided by the initial reporter: "having issues with the labels peeling off the 5 ml syringes.I unfortunately do not have any examples of the 5 ml to show you.".

Event Description

No additional information.

Manufacturer Narrative

(b)(4) ¿ follow up mdr for device evaluation: one photo of a 10 ml syringe was received by bd.A quality engineer was able to review the photo from an unknown lot number regarding material number 309605.The image shows a loose syringe in an unknown bag filled with a clear unknown fluid with a sticker affixed to the non-scale marking side; however, some of the sticker is not fully affixed to the barrel and is hanging off.The reported defect cannot be confirmed from the photo provided.The condition observed is acceptable per product specification.The reported defect cannot be confirmed from the photo provided.A physical sample is required for a more thorough evaluation and potential root cause determination.A device history record review was completed for provided lot number 3114363 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.

• 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: 18016615
• MDR Text Key: 326725930
• Report Number: 1213809-2023-01180
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096054
• UDI-Public: (01)30382903096054
• Combination Product (y/n): Y
• Reporter Country Code: CA
• 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: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309605
• Device Lot Number: 3114363
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1