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

Catalog Number	301692
Medical Device Problem Code	Packaging Problem (3007)
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 bd blunt fill needle had mix product in pack.The following was translated from german to english: the product is a blunt needle, it is so that pointed needles have been found in the batch mentioned.
Additional Manufacturer Narrative
E1: initial reporter phone#: (b)(6).H3: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H6: investigation summary it was reported there were sharp needles found in a blunt needle batch.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number (b)(4), 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, but it could be possible the customer received escapes from the incident.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.H3 other text : see h10.
Event or Problem Description
It was reported that the bd blunt fill needle had mix product in pack.The following was translated from german to english: the product is a blunt needle, it is so that pointed needles have been found in the batch mentioned.

• Brand Name: BD BLUNT FILL NEEDLE
• 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: 17896049
• Report Number: 1911916-2023-00742
• Device Sequence Number: 14294444
• Product Code: FMI
• UDI-Device Identifier: 30382903016922
• UDI-Public: (01)30382903016922
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: Health Professional
• Device Catalogue Number: 301692
• Device Lot Number: 1273700
• 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: 09/21/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• 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