MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305136
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported while using bd precisionglide¿ 27 g x 1-1/4" hypodermic needles the needle was clogged.This occurred 15 times.There was no report of patient impact.The following information was provided by the initial reporter: solution won't come out of the needle.
Event or Problem Description
It was reported while using bd precisionglide¿ 27 g x 1-1/4" hypodermic needles the needle was clogged.This occurred 15 times.There was no report of patient impact.The following information was provided by the initial reporter: solution won't come out of the needle.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, it has been determined that the is a duplicate of 1911916-2022-00706 this supplemental is to cancel mdr.

• Brand Name: BD PRECISIONGLIDE¿ 27 G X 1-1/4" HYPODERMIC NEEDLES
• 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): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15929428
• Report Number: 1911916-2022-00711
• Device Sequence Number: 6562834
• Product Code: FMI
• UDI-Device Identifier: 30382903051367
• UDI-Public: (01)30382903051367
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 12/19/2022

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 Model Number: 305136
• Device Catalogue Number: 305136
• Device Lot Number: 2056770
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2022
• 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