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

Model Number	305167
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
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.E.1.The customer's address is unknown.Unknown, (b)(6), 00000 usa has been used as a default.H.6.Investigation summary: a device history record review was completed by our quality engineer team for provided material number 305167 and lot number 2228394.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that while using the bd conventional needles there was a small hole in the hub that caused leakage.Report 2 of 2.The following was recieved by the initial reporter: verbatim: on 2 separate occasions, one of our providers has gone to give an injection using the bd precision glide 21g x 1 1/2 " needle and they have had a small hole in the needle hub that caused the medication from the syringe to shoot out the side of the needle hub rather than through the needle itself.Did the two separate event occurs on the same incident date ((b)(6)2023)? no, i was made aware of the issue on the 2nd incident date of (b)(6)2023.The first incident occurred last week ((b)(6)2023) however it was from the same lot.

• Brand Name: BD CONVENTIONAL NEEDLES
• 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: 17339419
• Report Number: 1911916-2023-00491
• Device Sequence Number: 20556258
• Product Code: FMI
• UDI-Device Identifier: 30382903051671
• UDI-Public: (01)30382903051671
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 06/28/2023

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: 305167
• Device Catalogue Number: 305167
• Device Lot Number: 2228394
• 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: 06/26/2023
• Initial Report FDA Received Date: 07/17/2023
• 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