MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ SYRINGE STERILE; PISTON SYRINGE

Catalog Number	309572
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	08/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd luer-lok¿ syringe experienced foreign matter.The following information was provided by the initial reporter: customer injected as normal.Extensive soreness after a prolonged period in the injection area.Unscrewed the needle from the hub to inspect- found brown foreign matter contaminant.Customer mentioned additional physical and neurological symptoms, but did not directly blame the injection.A visit to the hospital is scheduled.Has the sample and will send it in if provided labels.Add info received: 1st customer response could you kindly provide the address for us to create a return label? (b)(6).Could you provide the photo/video of the reported issue? please see photos.Where was the foreign matter (fm) located? it was located in the tip of the syringe and the needle plastic base.In the fluid path? the contaminant was in the fluid path.Is the fm able to be removed or is it embedded in the plastic / needle? the fm is able to be removed.What is the patient outcome? are there any adverse events/serious injuries? i am still experiencing pain and inflammation at and around the injection site.Was there any medical intervention involved to treat the symptoms? analgesics and reduced activity.Did the patient recovered from the symptoms? initial symptoms are getting better, however, i am now experiencing muscle spasms in the surrounding muscules.Was there a delay of, or change in, the course of treatment due to the event? yes.What type of procedure is being performed? testosterone intramuscular injection (right thigh).What was the medication/fluid in use at the time of the event? testosterone.
Additional Manufacturer Narrative
(b)(4) ¿ follow up mdr for device evaluation.It was reported there was a brown foreign matter contaminant.As a sample was not returned, a thorough sample evaluation could not be completed.To aid in the investigation, eight photos of a 3ml luer-lok syringe with a 22x1" needle from lot 1019402 was received for evaluation by our quality team.Two of the images show the syringe in an unsealed package next to a bag containing a label with the patient's information, with one of the images showing the top web graphics which includes all applicable product information.Three photos show an unknown reddish-brown spot inside the tip of the barrel.Two images show a reddish-brown spot at the tip area in the opened packaging blister.One photo shows a reddish-brown spot in the needle hub.A device history record review was completed for provided material number 309572, lot 1019402.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 1019402 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.The review also revealed all applicable housekeeping tasks were completed each shift through the entirety of the production run of this batch.Batch 1019402 is considered in compliance with our product specification requirements.Based on the investigation, the reported defect cannot be confirmed to have originated at the manufacturing plant.A physical sample is required for additional analysis, a more thorough evaluation and potential root cause determination.Therefore, no corrective action is required at this time.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.

• Brand Name: BD LUER-LOK¿ SYRINGE STERILE
• Common Device Name: 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17750003
• Report Number: 1213809-2023-01008
• Device Sequence Number: 17933428
• Product Code: FMF
• UDI-Device Identifier: 30382903095729
• UDI-Public: (01)30382903095729
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: 12/31/2025
• Device Catalogue Number: 309572
• Device Lot Number: 1019402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown