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	Break (1069)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
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 9th complaint for lot # 9078975 for shield tight.This is the 2nd complaint for needle broken.This is the 1st complaint for needle stick injury.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 cap was hard to remove before use, and the needle 23x1-1/4 rb broke off and pricked the patient.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "review case for tpc needle cap was hard to remove on pre-filled syringes and needle would break and stab patient.No other information was provided.".

• 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: 10075828
• Report Number: 1911916-2020-00478
• Device Sequence Number: 19418623
• 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: 05/20/2020
• 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