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

Catalog Number 305902

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 11/02/2023

Event Type  malfunction  

Event Description

Hold vm it was reported that the bd safety-lok needle pulled out of the hub.The following information was provided by the initial reporter: "bd needle dislodged from the hub when giving an injection." response received on 07-nov-2023: 1.Are you able to provide the date of incident? weekend of (b)(6) 2023.2.Please confirm the quantity of defective needle that was inspected.1 3.What was the patient outcome? see provider report above.4.Was there any adverse event or serious injury involved? adverse event but no serious injury as the patient did not close their mouth after syringe removal.Provider was able to remove the needle with a gloved hand.5.What type of procedure was being performed? dental block 6.Was the needle remained in patient? are you able to retrieve the needle form patient? it was removed.7.Was the procedure completed as planned? how was it resolved? procedure was completed.Provider removed free needle with gloved hand.Below is the report from the provider who was completing the procedure."yes, i was in the middle of doing a dental block and once i completed it, i pulled the needle with syringe.However, the needle stayed in placed coming off the hub itself.I had to manually pull out the needle and the patient didn't notice it.".

Manufacturer Narrative

Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a1205 - loose or intermittent connection.Patient problem code: f26 ¿ no health consequences or impact.

Manufacturer Narrative

(b)(4): follow up mdr for device evaluation no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.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 of the affected device.Examination of the product involved may provide clarification as to the cause for the reported failure.We regret any inconveniences this incident may have caused you and your facility.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

No additional information.

• Brand Name: BD SAFETY-LOK
• Type of Device: SAFETYGLIDE NEEDLES
• 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: 18228934
• MDR Text Key: 329262006
• Report Number: 1213809-2023-01353
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951254
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305902
• Device Lot Number: 2188484
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1