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

Catalog Number	305185
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	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: community hospital (aka (b)(6) healthcare system).Investigation summary: it was reported the epoxy was excessive on the needle.To aid in the investigation, one sample in an opened packaging blister with the plastic shield was received for evaluation by our quality team.A visual inspection was performed and the unit has an epoxy drip over 1/8" from the needle tip.No other defects or imperfections were observed.This defect could occur during the assembly process.During manufacturing, the plastic hub is placed under the cannulator then the needle is positioned and assembled to the plastic hub adding the white epoxy to fix it; after that, a plastic shield is assembled.In this case, a jam may have occurred at the cannulator inducing the white epoxy drip over on the needle.A device history record review was completed for provided material number 305185, lot number 1266869.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the cannulator was performed.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.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the bd precisionglide¿ needle experienced epoxy on the needle.The following information was provided by the initial reporter: excessive material that keeps the needle in place located on the top of the needle.Appears to be the goop used to attach the needle to the hub on the tip of the needle.Injuries or adverse event: no.

• 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: 14750111
• Report Number: 1911916-2022-00307
• Device Sequence Number: 16713344
• Product Code: FMI
• UDI-Device Identifier: 00382903051854
• UDI-Public: 00382903051854
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 05/25/2022

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: Other
• Device Catalogue Number: 305185
• Device Lot Number: 1266869
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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