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

Catalog Number	305903
Medical Device Problem Code	Incomplete or Inadequate Connection (4037)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/14/2023
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
It was reported that the bd safetyglide needle separated from the syringe.The following information was provided by the initial reporter: "the needle and syringe separated while the nurse was admin the vaccine and she was splashed in the eye by the vaccine." additional information provided on 12/05/2023: date of incident (b)(6) 2023 full dose of vaccine was not administered , repeat dose recommended by moderna subjecting child to second injection.Do you want the actual needle and syringe used? it was disposed immediately by the nurse.Or do you want one from our inventory? no further information provided by reporter.
Additional Manufacturer Narrative
Pr 9282283¿ follow up mdr for device evaluation one sample of a 1 ml safetyglide combo needle was received by bd.A quality engineer was able to review the sample from lot number 3255514 regarding material number 305903.The sample was received in a sealed package with all applicable product information.The syringe and needle mated with no discernable problem.The condition observed is acceptable per product specification.The reported defect was not identified in the samples received.Therefore, no corrective action is required currently.Lot 3255514 is considered in compliance with our product specification requirements.It is recommended to hand tighten the needle onto the syringe prior to use.A device history record review was completed for provided lot number 3255514 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.H3 other text : see h10 manufacture narrative.
Event or Problem Description
No additional information.

• Brand Name: BD SAFETYGLIDE
• Common Device Name: 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: 18325315
• Report Number: 1213809-2023-01452
• Device Sequence Number: 7438076
• Product Code: FMI
• UDI-Device Identifier: 30382903059035
• UDI-Public: (01)30382903059035
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2024

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: 305903
• Device Lot Number: 3255514
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 03/04/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown