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

Catalog Number	301692
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the blunt fill needle precisionglide¿ has a needle defect.The following was received by the initial reporter: we have come across an issue with a lot of needles that we purchased from becton dickinson.It has been brought to our attention that a number of these needles did not have blunted tips, but rather flat sharp end.
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.6.Investigation summary: it was reported a number of these needles did not have blunted tips, but rather a flat sharp end.To aid in the investigation, twenty-one samples in sealed packaging blisters and one photo was received for evaluation by our quality team.A visual inspection was performed, and the needle assemblies have a flat needle tip.The photo provided shows a similar needle assembly to the samples received.A device history record review was completed for provided material number 301692, lot 1273700.One related issue was identified, a quality notification was issued, and material was segregated.All processes and final inspections complied with specification requirements.The segregation of the material must not have been effective, and the customer received escapes from this event.The samples will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 10-oct-2023 h.6.Investigation summary: it was reported a number of these needles did not have blunted tips, but rather a flat sharp end.To aid in the investigation, twenty-one samples in sealed packaging blisters and one photo was received for evaluation by our quality team.A visual inspection was performed, and the needle assemblies have a flat needle tip.The photo provided shows a similar needle assembly to the samples received.A device history record review was completed for provided material number 301692, lot 1273700.One related issue was identified, a quality notification was issued, and material was segregated.All processes and final inspections complied with specification requirements.The segregation of the material must not have been effective, and the customer received escapes from this event.The samples will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
Event or Problem Description
It was reported that the blunt fill needle precisionglide¿ has a needle defect.The following was received by the initial reporter: we have come across an issue with a lot of needles that we purchased from becton dickinson.It has been brought to our attention that a number of these needles did not have blunted tips, but rather flat sharp end.

• Brand Name: BLUNT FILL NEEDLE PRECISIONGLIDE¿
• 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17946859
• Report Number: 1911916-2023-00774
• Device Sequence Number: 12818334
• Product Code: FMI
• UDI-Device Identifier: 30382903016922
• UDI-Public: (01)30382903016922
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 10/18/2023

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: 301692
• Device Lot Number: 1273700
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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