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

Catalog Number	305110
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one bd precisionglide¿ needle had a foreign piece of plastic attached to the end of it.The following information was provided by the initial reporter: "today customer saw a smill piece of plastic ( and not from wrapper) but sutomrt says when thet removed needle from crtridge to shee if islune whould come out pushing pluger with needle not in cartridge they notes this smil piece of plastic stuck and the end off needle that was causing blockage customer was able to remove that small piece of plastice".
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: unknown.Investigation summary: to aid in the investigation, two samples and a tandem cartridge were received for evaluation by our quality team.One sample came in an opened packaging blister connected to a 3ml exel brand syringe.The other sample came in an opened packaging blister.The tandem cartridge came in a sealed packaging blister.A visual inspection was performed to the needle assemblies and no defects or imperfections were observed.Each sample was then connected to a syringe with saline solution.The needle connected to the 3ml exel syringe expelled the solution with a normal flow.The other needle did not expel the solution; this needle is clogged.It could be possible that while passing the needle through the stopper vial or cartridge the needle became clogged with the stopper material.A device history record review was completed for provided material number 305110, lot number 0072110.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There are quality controls currently in place to detect this type of defect during the production process such as a vision system that inspects 100% of all products for clogged needles.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.Our quality 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15474789
• Report Number: 1911916-2022-00521
• Device Sequence Number: 2892597
• Product Code: FMI
• UDI-Device Identifier: 00382903051106
• UDI-Public: (01)00382903051106
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/12/2022

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: Lay User/Patient
• Device Expiration Date: 04/30/2025
• Device Catalogue Number: 305110
• Device Lot Number: 0072110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2020
• 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