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

Catalog Number	305167
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a crack in the bd precisionglide¿ needle hub caused leakage during use.The following information was provided by the initial reporter: "can you please describe the failure in more detail? a syringe was observed the leak at the luer collar area when manually dispensing contents with an attached bd needle as part of product design verificaition testing.The needle utilized was a bd precision glide 21g 1.5 inch needle (catalog number: 305167; lot number: 0363845).Following this event, an investigation was conducted to identify the root-cause of the leak which was observed to be a crack on the needle hub.".
Additional Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 a crack in the bd precisionglide¿ needle hub caused leakage during use.The following information was provided by the initial reporter: "can you please describe the failure in more detail? a syringe was observed the leak at the luer collar area when manually dispensing contents with an attached bd needle as part of product design verificaition testing.The needle utilized was a bd precision glide 21g 1.5 inch needle (catalog number: 305167; lot number: 0363845).Following this event, an investigation was conducted to identify the root-cause of the leak which was observed to be a crack on the needle hub".
Additional Manufacturer Narrative
The following fields have been updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 20-sep-2023.H6: investigation summary: it was reported there was observed to be a crack on the needle hub.To aid in the investigation, one sample with no packaging blister and two photos were provided for evaluation by our quality team.A visual inspection was performed with 10x magnification.The needle hub has a crack at the bottom 3/8" long.The sample was connected to a syringe with saline solution and there was leakage through the hub crack.The two photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if the fixture holding the needle hub was not properly centered when the plastic shield was assembled.A device history record review was completed for provided material number 305167, lot 0363845.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.The shield assembly process was verified.The settings were correct, and the flow of product was good.To date, there have been no other similar events reported for this lot.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.

• Brand Name: BD PRECISIONGLIDE¿ 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 ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17762498
• Report Number: 1911916-2023-00669
• Device Sequence Number: 12506743
• Product Code: FMI
• UDI-Device Identifier: 00382903051670
• UDI-Public: 00382903051670
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 09/25/2023

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 Expiration Date: 02/28/2026
• Device Catalogue Number: 305167
• Device Lot Number: 0363845
• 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: 08/30/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/17/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2020
• 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