MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN. WITH 3 ML SYRINGE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305924
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.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 safetyglide¿ needle 25 g x 1 in.With 3 ml syringe the safety mechanism failed.There was no report of patient impact.The following information was provided by the initial reporter: complaint: safety mechamism was not working properly and made the needle bent occurrence: 1.Customer request replacement for 6 boxes of product.
Event or Problem Description
It was reported while using bd safetyglide¿ needle 25 g x 1 in.With 3 ml syringe the safety mechanism failed.There was no report of patient impact.The following information was provided by the initial reporter: complaint: safety mechamism was not working properly and made the needle bent occurrence: customer request replacement for 6 boxes of product.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 21-sep-2023.H6: investigation summary: it was reported the safety mechanism was not working properly and made the needle bend.To aid in the investigation, three samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The safety mechanism was activated on each sample and there were no issues with the activation.A device history record review was completed for provided material number 305924, lot 3180205.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be determined.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE 25 G X 1 IN. WITH 3 ML SYRINGE
• 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17643084
• Report Number: 1911916-2023-00618
• Device Sequence Number: 7769637
• Product Code: FMI
• UDI-Device Identifier: 30382903059240
• UDI-Public: (01)30382903059240
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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: 305924
• Device Lot Number: 3180205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/10/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 08/29/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• 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