MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD® NEEDLE 27 G X 1 1/2 IN. SINGLE USE, STERILE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	301629
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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® needle 27 g x 1 1/2 in.Single use, sterile there was no resistance.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: not giving resistance when medications are pushed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: correction: b5: describe event or problem: it was reported while using bd® needle 27 g x 1 1/2 in.Single use, sterile there was resistance.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: giving resistance when medications are pushed.
Event or Problem Description
It was reported while using bd® needle 27 g x 1 1/2 in.Single use, sterile there was resistance.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: reported issue: giving resistance when medications are pushed.
Additional Manufacturer Narrative
A device history record review was completed by our quality engineer team for provided material number 301629 and lot number 2279890.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.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
No additional information.

• Brand Name: BD® NEEDLE 27 G X 1 1/2 IN. SINGLE USE, STERILE
• 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 ; 8448235433
• MDR Report Key: 17276162
• Report Number: 1911916-2023-00465
• Device Sequence Number: 12055327
• Product Code: FMI
• UDI-Device Identifier: 30382903016298
• UDI-Public: (01)30382903016298
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/25/2024

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: 301629
• Device Catalogue Number: 301629
• Device Lot Number: UNKNOWN
• 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: 06/14/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 07/18/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 07/24/2023; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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