MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305900
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported the the bd safetyglide¿ needle safety mechanism failed.The following was received from the initial reporter "the safety device only came to about half the length of the needle¿.
Event or Problem Description
No additional information received.Mat#:305900, lot#2251205.It was reported by customer that the safety device only came to about half the length of the needle.Verbatim: rcc received the complaint via email.Email as attached.¿provided a im short for a pt and used safetyglide needle 3232gx1 ½¿ ref 305900 lot 2251205.The safety device only came to about half the length of the needle.¿.
Additional Manufacturer Narrative
Pr 8792389 follow up.It was reported the safety device only came to about half the length of the needle.As a sample was not returned, a thorough sample evaluation could not be completed.A device history record was reviewed for provided material number 305900, lot 2251205.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2251205 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Additional device histories were reviewed for each batch of needles used in the manufacturing of this batch, and there was no documentation of this defect during the entire production run of the batches.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed, a potential root cause could not be determined, and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.

• Brand Name: BD SAFETYGLIDE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17761037
• Report Number: 1213809-2023-01019
• Device Sequence Number: 12555787
• Product Code: FMI
• UDI-Device Identifier: 30382903059004
• UDI-Public: (01)30382903059004
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 01/20/2024

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: Health Professional
• Device Catalogue Number: 305900
• Device Lot Number: 2251205
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 01/20/2024
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 01/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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