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

Catalog Number	305271
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	09/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 305271 batch#: 2308376.It was reported that the bd integra had a needle retraction failure.The following information was provided by the initial reporter: verbatim: complaint received via email(s) attached.Rcc received a complaint via community.Pir attached.During code white situation pt required im injection, needle would not retract, needle removed and poked general service worker arm.Product code: 305271.
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
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) - supplemental mdr - needle retraction failure (integra).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.

• 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: 20490201
• Report Number: 1213809-2024-00736
• Device Sequence Number: 3553528
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715(11)221104(17)271031(10)2308376
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K011103
• 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): 12/12/2024

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: 305271
• Device Lot Number: 2308376
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 10/20/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown