MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL NEEDLE 23X1-1/4 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305120
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.Investigation conclusion: based on no sample, the investigation concluded, bd was not able to verify the indicated failure.This is the 3rd complaint for lot # 9078975 for shield tight.The is the 1st complaint for needle broken, leakage other.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: no root cause can be determined as no samples were received.Rationale: capa not required at this time.
Event or Problem Description
It was reported that the needle 23x1-1/4 rb was difficult to remove from the packaging and had to be extracted with pliers, where it broke during the process.Additionally, it was reported that the needle leaked "avonex" from the syringe connection.All defects occurred during use.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "patient stated they had difficulty removing needle from plastic packaging.Patient attempted to extract with fingers but was unable to.Patient grabbed pliers to remove needle from packaging.Patient stated they had to clamp down very hard to get enough force to pull the needle out of the packaging.Patient attached needle to pre-filled syringe.While injecting patient noticed medication leaked out of the point where the needle attaches to the pre-filled syringe and had leaked onto the floor.Patient did have 3 more pfs on hand to inject with.Confirmed with patient that it was a 30mcg pre-filled syringe.Lot# pc0136.Follow up: patient said the needle was impossible to remove from the cap.Patient does not have the sample as someone called and told her to dispose of it.Patient said she used pliers to remove the needle and the bottom part of the needle broke during the process.She attached the needle and tried to inject but the medication leaked out without going into the needle.Patient said lately the needle was difficult to detach from the cap and this happened when she first started avonex years ago.".

• Brand Name: NEEDLE 23X1-1/4 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 10070264
• Report Number: 1911916-2020-00473
• Device Sequence Number: 3924056
• Product Code: FMI
• UDI-Device Identifier: 30382903051206
• UDI-Public: 30382903051206
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/11/2020

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: Lay User/Patient
• Device Expiration Date: 04/30/2024
• Device Model Number: 305120
• Device Catalogue Number: 305120
• Device Lot Number: 9078975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other