MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETY-LOK; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305902
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2024
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
Material#: 305902.Batch#: 4082651.It was reported that the bd safety-lok needle pulled out of the hub.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Injuries or adverse event: no item: 305902 quantity affected: 1 bx.Serial/lot number: (b)(4).Po : (b)(4).Are any samples available for return? yes reported issue: 7/31 cst emailed in stating that the needle came out of the hub and stayed in the patient thigh, safety slide malfunction additional information provided: there wasn¿t any serious injury to the patient or to myself.The date of the incident was around (b)(6) 2024.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle pulled out of hub.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 SAFETY-LOK
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 20022777
• Report Number: 1213809-2024-00571
• Device Sequence Number: 15601055
• Product Code: FMI
• UDI-Device Identifier: 30382903059028
• UDI-Public: (01)30382903059028(11)240322(17)290228(10)4082651
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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: 305902
• Device Lot Number: 4082651
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown