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

Catalog Number	309659
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd luer-lok had a syringe needle connectivity issue.The following information was provided by the initial reporter: "when using the 1ml tuberculin slip tip syringe with bd eclipse needle separation occurs at the junction point causing the unsafe situation as the needle is exposed before administering medication and there is a chance of staff accidentally poking themselves.Another incident occured where the syringe dislodged from the needle while withdrawing the injection, leaving the needle in the patients body.The needle had to be then removed separately, creating unsafe situation." impact of incident: outcome was prolonged agitation for the patient as the medication administration was delayed.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2023.Site name/location: (b)(6) medical centre.Level of harm: no apparent harm ¿ close call.Ahs optional report to cmdsnet (health canada): incident details: when using the 1ml tuberculin slip tip syringe with bd eclipse needle separation occurs at the junction point causing the unsafe situation as the needle is exposed before administering medication and there is a chance of staff accidentally poking themselves.Another incident occured where the syringe dislodged from the needle while withdrawing the injection, leaving the needle in the patients body.The needle had to be then removed separately, creating unsafe situation.Impact of incident: outcome was prolonged agitation for the patient as the medication administration was delayed.Who was affected? patient.Device name/description: syringe slip tip tuberculin sterile latex free disposable 1ml manufacturer: becton dickinson canada inc.Manufacturer code/model: 309659.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd): unknown.Supplier: (b)(4).Supplier catalogue number: 308-309659.Was the device retained? no.Additional information received on 01/05/2024: 1.Any sample or photo available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? no.2.Please confirm the date of event of both the incident.1st incident (b)(6) 2023 / 2nd incident around the same time exact date unknown.3.Did the event directly, or indirectly involve a patient or user? before use in nov 16 incident, during use in the other incident.4.Did the event involve an urgent/life threatening medical situation? no ¿ close call.5.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Please include treatment/intervention provided and the outcome.Outcome was prolonged agitation for the patient as the medication administration was delayed.
Additional Manufacturer Narrative
(b)(4) - follow up mdr for device evaluation.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.It is recommended to hand tighten the needle onto the syringe prior to use.We would be very interested in examining product that does not meet your expectations and our quality standards.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.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
• 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: 18528440
• Report Number: 1213809-2024-00007
• Device Sequence Number: 7727660
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• 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): 01/17/2024

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: Other
• Device Catalogue Number: 309659
• Device Lot Number: 2355450
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 12/21/2023
• Initial Report FDA Received Date: 01/17/2024
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown