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 Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: a device history record review was completed for provided material number (b)(4) and lot number (b)(4).The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, two physical samples were received for evaluation by our quality team.One sample came with a packaging blister labeled as avonex (interferon beta-1a) 30mcg/0.5ml for intramuscular injection.The sample came connected to a syringe with 0.25ml of a drug.The needle assembly was disconnected to perform a visual inspection and no defects or imperfections were observed.A shield pull test was performed and the result was within specification.The sample was then connected to a syringe with saline solution.No leakage was observed and the solution was expelled with normal flow.The second sample came with two packaging blisters top web from avonex and one empty syringe also labeled as avonex.The needle assembly came in an opened packaging blister.A visual inspection was performed and no defects or imperfections were observed.A shield pull test was performed and the result was within specification.The sample was then connected to a syringe with saline solution.No leakage was observed and solution was expelled with normal flow.Based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that a piece of the needle 23x1-1/4 rb syringe tip broke off when attempting to remove the cap.The following information was provided by the initial reporter: "needle cap; impossible to open/detach could not get cap off, piece of syringe broke.The nurse stated that the syringe broke at the tip.The nurse stated that the white collar (ovs) is not attached to the syringe.The person who administered the product was a caregiver (nurse).".

• 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: 11340890
• Report Number: 1911916-2021-00136
• Device Sequence Number: 4568472
• 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): 02/08/2021

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: 11/30/2024
• Device Model Number: 305120
• Device Catalogue Number: 305120
• Device Lot Number: 9269963
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1