MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 5ML LS SP125; PISTON SYRINGE

Catalog Number	309647
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material# 309647, batch# 3282432.It was reported the bd syringe 5ml ls sp125 with stopper angularity.The following information was provided by the initial reporter: verbatim: email from xx:, hi vendor rep, please follow up with xxxx at (b)(6) for the product concern outlined below within 3 business days; and advise of any special shipping instructions for pick up, courier or discarding of product.Please investigate and follow up with a written report from your quality assurance as to your findings and resolutions.Product concern ticket number: (b)(4).Date of incident: (b)(6) 2024, hospital: other, department: laboratory, product: syringe 5ml ls slip tip without needle, vmid: (b)(4), lot number: 3282432, product expiry date: 30-sep-2028, number of defective product(s): 500, is sample available: no, concern description: the rubber top on the plunger is not linear and not equal wide.Plunger cannot be moved safely, so syringe cannot be used for collecting blood thank you in advance for your follow-up on this product concern.Email from (b)(6): hello, we have received the below product problem report.(b)(6), ref# (b)(4) has been assigned to this issue.Upon completion, please provide a quality investigation letter detailing your findings.Please advise on next steps for quality investigation and customer resolution: product problem report: product information, product code: 309647, product description: syringe hypo 5cc l/s bx/125, lot/serial #:(b)(6), expiry date: 2028-09-30.Problem information: cite customer complaint # (b)(4) the rubber top on the plunger is not linear and not equal wide.Plunger cannot be moved safely, so syringe cannot be used for collecting blood note: i have requested further details on the 500 individual incidents reported occurrences: 500 each.Site information: pending, pending, pending, pe, pending.Sample information: incident samples: 0, representative samples: 0.No adverse event reported.
Additional Manufacturer Narrative
Pr (b)(4)- supplemental mdr - stopper angularity.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 5ML LS SP125
• Common Device Name: 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: 20330383
• Report Number: 1213809-2024-00678
• Device Sequence Number: 21239627
• Product Code: FMF
• UDI-Device Identifier: 30382903096474
• UDI-Public: (01)30382903096474(11)231009(17)280930(10)3282432
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 309647
• Device Lot Number: 3282432
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/29/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown