MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305155
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.This is the 1st complaint for the lot# 5336578 for the same defects or symptoms.There was no documentation of issues for the complaint of batch #5336578 during the production run.No root cause can be determined as no samples were received.
Event or Problem Description
It was reported that during use of the bd precisionglide needle that syringe needle broke off of syringe while drawing and was stuck in the vial.The needle broke off in consumers leg and in the vial.From phone call on (b)(6) 2019 16:06:07: consumer called, i updated the contact information.Problem occurred about 3 weeks ago.Consumer also stated that one needle broke off in his leg during injection, he removed it with his fingers, no medical intervention, no injury.Samples were discarded, sending replacement box to the pharmacy.Pharmacist reported on behalf of consumer that syringe needle broke off of syringe while drawing and was stuck in the vial.Occurrence date is unknown, lot # 5336578, product # 305155, exp 1-31-2021.

• Brand Name: BD PRECISIONGLIDE¿ NEEDLE
• 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: 8433301
• Report Number: 1911916-2019-00283
• Device Sequence Number: 19245224
• Product Code: FMI
• UDI-Device Identifier: 30382903051558
• UDI-Public: 30382903051558
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 305155
• Device Lot Number: 5336578
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 03/19/2019
• 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