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

Catalog Number	305271
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	08/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material # 305271 batch # 3348888 it was reported that the bd integra "needle was in the syringe".The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.I just got discharged and the needle was in the syringe.The needle is not viewable to see that it ends up in the syringe is one issue, you can¿t shake the syringe to hear the needle and the needles don¿t have an explanation on them explaining how it works.I got them from cvs and never used these before.Nobody from the pharmacy explained this to me and they don¿t come in a box that explains so it¿s a big issue.The doctor at the er informed me this has happened several times where people are coming in thinking the needle came off.It¿s a terrible design.Customer response on (b)(6) 2024 1.Can you please provide an exact date of event in format mm-dd-yyyy? 08/03/2024 2.Could you please provide a further description of the issue? i purchased needle/syringe from cvs.They came in a ziplock style bag and had only the package on the syringe/needle.Instructions on how this bd integra syringe are not on the packaging.I did my injection and the needle was gone off the tip of the syringe.I shook the syringe and didn¿t see anything and looked at it and didn¿t see anything.I searched the floor for the needle and couldn¿t find it, so thought it was stuck under my skin in my glute.I then went to urgent care with the syringe and packaging and told i need to go to the er.I went to er and provided the syringe and packet, they thought it was under my skin as well so did x-rays.The x-ray didn¿t show it so we broke the syringe apart and used a flashlight to look in tube that is milk colored to see needle.It¿s irresponsible to sell these like this without instructions or explanation on how the needles work.3.Can you please provide the material and lot number associated with reported issue? 2028-11-30cav.01 lot 3348888 4.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.As a result of no instructions or explanation on package how the syringe works or guidance from pharmacy i thought i had a needle stuck in my muscle under the skin.It was extremely stressful and i had to drive to the emergency room and undergo x-rays.5.Any sample available for investigation? if yes, are you able to provide the address of the facility for us to ship the return label? yes, sure i can send it.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
(b)(4) follow up mdr for device evaluation/correction.Correction: following submission of initial mdr, the lot number was not correctly reported.Section d updated to reflect correct lot number.Evaluation: one sample was provided to our quality team for investigation.The sample was received with the opened package with all applicable product information on the top web, and all components separated.The needle was found to be inside the inner plunger rod as designed.The condition observed is acceptable per product specification.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.

• 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: 20047343
• Report Number: 1213809-2024-00577
• Device Sequence Number: 7955682
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K011103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 305271
• Device Lot Number: 3348888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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