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

Catalog Number	305198
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd® needle 1 1/2 in.Single use, sterile broke.The following was translated from spanish to english: i hereby inform that yesterday, august 27, i was notified that when i was preparing medication, the needle broke and only the base remained in the syringe (evidence attached), it is worth mentioning that the nurse mentioned not having applied force since she was barely loading the injectable water.
Additional Manufacturer Narrative
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 that the bd® needle 1 1/2 in.Single use, sterile broke.The following was translated from spanish to english: i hereby inform that yesterday, august 27, i was notified that when i was preparing medication, the needle broke and only the base remained in the syringe (evidence attached), it is worth mentioning that the nurse mentioned not having applied force since she was barely loading the injectable water.
Additional Manufacturer Narrative
H.6.Investigation summary: it was reported the needle broke and only the base remained in the syringe.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a syringe with solution.There is a damaged needle hub.The bottom part of a needle hub is assembled to the syringe.In the other photo, the top part of the needle assembly is next to the syringe inside the plastic shield.Next to the units in this photo is a packaging blister.No other information could be obtained from the photo.A device history record review was completed for provided material number 305198, lot 2228437.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 photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be determined.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.

• Brand Name: BD® NEEDLE 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17745673
• Report Number: 1911916-2023-00649
• Device Sequence Number: 5654287
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,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: 305198
• Device Lot Number: 2228437
• 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: 08/28/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 09/14/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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