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

Catalog Number	309592
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd safety-lok had foreign matter.The following information was provided by the initial reporter: "3cc syringes have black pieces." verbatim: rcc received a complaint via email.Email(s) attached.Medline complaint #: (b)(4).Defect description: 3cc syringes have black pieces.Medline part #: (b)(4).Product description: syr 3ml l/l.Vendor part #: 301073 lot #: unknown date reported: (b)(6) 2024 sample received: yes.Response needed: summary of findings and corrective action.Complaint reported to fda as mdr-30 day.Reference no.(b)(4).Additional information provided on 03/27/2024: please provide the batch# number? unknown.Kindly provide the address of the facility for us to ship the return label.No sample available.Did the event directly, or indirectly involve a patient or user? no patient involvement reported.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.E.4.The initial reporter also notified the fda, medwatch report 1423395-2024-00317.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
As no physical sample, valid part number or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD SAFETY-LOK
• Common Device Name: 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: 19095356
• Report Number: 1213809-2024-00225
• Device Sequence Number: 7407968
• Product Code: FMI
• UDI-Device Identifier: 30382903095927
• UDI-Public: (01)30382903095927
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K944757
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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: Other
• Device Catalogue Number: 309592
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 07/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown