MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY NEEDLE 22X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305156
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples were received.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.We would be very interested in examining product that does not meet your expectations and our quality standards.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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: this is the 1st complaint for lot # 8361924 for this type of defect or symptom.There was no documentation for this type of defects during the entire production run of these batch numbers.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.Root cause description: no root cause can be determined as no samples were received.
Event or Problem Description
It was reported that leakage occurred before use with a needle 22x1-1/2 rb.The following information was provided by the initial reporter, "it was reported that the needle was not securely connected to the syringe which cause the medication to leak.An investigation from becton dickinson is required.Bd lot number(s): 8361924.Please note: this report is for loose needle connection to swfi vial.Which needle is this complaint referring to below? needle.Did this complaint occur in or outside usa? in usa.Is the date of event known? (b)(6) 2020.Was there any adverse events due to the reported issue? medical intervention? course of treatment change? other actions? n/a.Are any patient identifiers available? (i.E.Gender, weight, ethnicity, etc.) patient identifiers will not be available for any investigation request.Will samples be returned for investigation? samples of dosing syringes and needles cannot be returned for further evaluation.Samples were discarded.".

• Brand Name: NEEDLE 22X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 9759602
• Report Number: 1911916-2020-00187
• Device Sequence Number: 14310655
• Product Code: FMI
• UDI-Device Identifier: 30382903051565
• UDI-Public: 30382903051565
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/13/2020

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: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 305156
• Device Catalogue Number: 305156
• Device Lot Number: 8361924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 02/26/2020
• 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