MAUDE Adverse Event Report: BECTON DICKINSON BD ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of shield damage was confirmed upon inspection of the photo.The assembly process was reviewed.The probable cause could be when the shield on the shield loading unit doesn't properly grip causing misalignment before loading it to the needle hub hence causing the needle bent or the tip of the cannula pierce through shield.The crash at the shield loading station caused parts to be jammed.The production technicians could have failed to remove the affected and neighboring rack on the shield loading track, allowing the affected parts to flow down the process.Action had been taken to re-train the production technician to clear all defective parts from the track at shield loading station when jam occurs.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.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.Our business team regularly reviews the collected data for identification of emerging trends.We regret any inconveniences this incident may have caused you and your facility.
Event or Problem Description
It was reported the bd eclipse 18x1-1/2 rb needle point penetrates through shield discovered a faulty 18g needle this pm on attempting to draw up a flush.Needle is bent and pierces through the white cap.She has kindly completed a riskman.I have informed the nco and she advised that there is nothing more to be done for now.I have attached a photo of the lot number in case a product recall is needed.I have checked the needles in the medication room and no others appear to have issues from outside the packaging.These are all from the same lot number.
Additional Manufacturer Narrative
Submitting b codes.Based on device history record review, no abnormality was observed during the production of the affected batches.The assembly process was reviewed.Probable cause could be when the shield on the shield loading unit not properly grip causing misalignment before loaded to the needle hub hence causing the cannula bent or the tip of the cannula pierce through shield.The crash at the shield loading station caused parts to be jammed.The production technicians could have failed to remove the affected and neighboring rack on the shield loading track hence allowing the affected parts to flow down the process.Action had been taken to re-train the production technician to clear all defective parts from the track at shield loading station when jam occurs.
Event or Problem Description
Discovered a faulty 18g needle this pm on attempting to draw up a flush.Needle is bent and pierces through the white cap.She has kindly completed a riskman.I have informed the nco and she advised that there is nothing more to be done for now.I have attached a photo of the lot number in case a product recall is needed.I have checked the needles in the medication room and no others appear to have issues from outside the packaging.These are all from the same lot number.

• Brand Name: BD ECLIPSE 18X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19850948
• Report Number: 2243072-2024-00829
• Device Sequence Number: 6821462
• Product Code: FMI
• UDI-Device Identifier: 00382903057665
• UDI-Public: (01)00382903057665
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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: 305766
• Device Lot Number: 4003134
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/29/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown