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

Catalog Number 305271

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/01/2024

Event Type  Injury  

Event Description

It was reported that the bd integra needle pulled out of the hub.The following information was provided by the initial reporter: "they received a testosterone shot and the needle stayed in their leg apart from the syringe.They stated that they had x-rays to make sure it was not stuck in their leg." additional information provided on 01/05/2024: 1.This is the batch etc of syringes that it came with not sure what numbers you need off the packages; 2.Im the patient after going to urgent care for 2 xrays then referred to the emergency room of the major hospital here for 10-12 more xrays it was deemed after the urgent care persons initial ray that the emergency room doctors couldn't see anything in the xrays and i was advised to keep an eye on my thigh etc just incase; 3.No adverse side effects as of yet this all happened at 9:30am on (b)(6) 2024 so its still a waiting game to see if anything happens; 4.I only have the packages from the rest of the syringes that came with the one i used.The original one is gone in the trash i have photos of the xrays taken that day and the doctors reports.

Manufacturer Narrative

E.1.Address was not located and (b)(6) was used.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

Pr 9488165 ¿ follow up mdr for device evaluation.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.Please note that this product has a retractable needle design.The metal cannula of the needle retracts into the inner plunger rod for safety.Refer to ifu for additional information.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.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 Description

No additional information.

• Brand Name: BD INTEGRA
• Type of Device: PISTON SYRINGE
• 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: 18560092
• MDR Text Key: 333439230
• Report Number: 1213809-2024-00021
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052715
• UDI-Public: (01)30382903052715
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305271
• Device Lot Number: 0113668
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other