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

Catalog Number	305166
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported there were defective needles with holes.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly with no plastic shield connected to a syringe.The syringe appears to be full of blood.There is a drop of the solution on the needle hub.No other information could be obtained from the photo.A device history record review was completed for provided material number 305166, lot number 1274214.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, and without the physical sample analysis a probable root cause could not be offered.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 the bd precisionglide¿ needle hub had a hole in it that caused leakage during use.The following information was provided by the initial reporter: "defect needles with hole cause leakage".

• 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16163912
• Report Number: 1911916-2022-00804
• Device Sequence Number: 18019467
• Product Code: FMI
• UDI-Device Identifier: 00382903051663
• UDI-Public: 00382903051663
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/28/2022

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: Other
• Device Catalogue Number: 305166
• Device Lot Number: 1274214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2022
• Initial Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown