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

Model Number	305198
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2088580 medical device expiration date: 31may2027 device manufacture date: 29mar2022 based on the investigation and with the sample analysis the symptom reported by the customer of needle bent is confirmed.However, the epoxy flaking off could not be confirmed.We will continue monitoring the complaint trend for the product and symptom.Probable root cause.It could be possible that a jam occurred at the cannulator inducing the symptom reported and not detected in the next processes.Verification of the cannulator was performed.Settings were correct.Flow of products was good.The sample will be shown to the associates for awareness.
Event or Problem Description
It was reported while using bd¿ needle 1 1/2 in.Single use, sterile there was epoxy on the needle.There was no report of patient impact.The following information was provided by the initial reporter: hospital setting serial compounding white glue between the hub and needle.White flakes are expanding and breaking off.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16441336
• Report Number: 1911916-2023-00105
• Device Sequence Number: 17496966
• Product Code: FMI
• UDI-Device Identifier: 30382903051985
• UDI-Public: (01)30382903051985
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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 Model Number: 305198
• Device Catalogue Number: 305198
• Device Lot Number: 2144497
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2023
• Initial Report FDA Received Date: 02/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2022
• 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