MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; SYRINGE, ANTISTICK

Catalog Number	305271
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	09/23/2024
Type of Reportable Event	Serious Injury
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 #: 305271.Batch#: 1054566.It was reported that the bd integra needle pulled out of the hub.The following information was provided by the initial reporter: verbatim: complaint received via email(s) attached.Rcc received a complaint via phone.Pir attached product complaint - pharmacist called to report on behalf of the customer, stating that the pt advised that the needle got stuck in the muscle after injecting and they were unable to remove the needle.Pt went to see a dr.And x-ray was performed but the needle could not be found.Ref: (b)(4) lot 1054566.
Additional Manufacturer Narrative
(b)(4).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 INTEGRA
• Common Device Name: SYRINGE, ANTISTICK
• 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: 20457816
• Report Number: 1213809-2024-00714
• Device Sequence Number: 8830855
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715(11)210223(17)260228(10)1054566
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Catalogue Number: 305271
• Device Lot Number: 1054566
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown