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

Model Number	305136
Medical Device Problem Codes	Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd precisionglide¿ needle was blocked by epoxy during the nerve blocker injection.The following information was provided by the initial reporter: "the needle was about to be used for an injection for nerve blocks, however, as the physician pressed down on the plunger, he felt that there was some type of resistance/there was something not right.He pulled the needle out and noticed a white material on the shaft of the needle.A different needle was used to complete the procedure".
Additional Manufacturer Narrative
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 the bd precisionglide¿ needle was blocked by epoxy during the nerve blocker injection.The following information was provided by the initial reporter: "the needle was about to be used for an injection for nerve blocks, however, as the physician pressed down on the plunger, he felt that there was some type of resistance/there was something not right.He pulled the needle out and noticed a white material on the shaft of the needle.A different needle was used to complete the procedure".
Additional Manufacturer Narrative
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 the bd precisionglide¿ needle was blocked by epoxy during the nerve blocker injection.The following information was provided by the initial reporter: "the needle was about to be used for an injection for nerve blocks, however, as the physician pressed down on the plunger, he felt that there was some type of resistance/there was something not right.He pulled the needle out and noticed a white material on the shaft of the needle.A different needle was used to complete the procedure".
Additional Manufacturer Narrative
H.6.Investigation: it was reported there was resistance was met and a white material was on the shaft of the needle.To aid in the investigation, one sample with the plastic shield, but no packaging blister, and one photo were provided for evaluation by our quality team.A visual inspection was performed.The needle has an epoxy drip over at the middle of the needle.No other defects or imperfections were observed.The sample was then connected to a syringe with saline solution.The solution expelled with a normal flow.The epoxy drip over 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, 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 305136, lot number 8228789.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.

• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12916304
• Report Number: 1911916-2021-01199
• Device Sequence Number: 12159853
• Product Code: FMI
• UDI-Device Identifier: 30382903051367
• UDI-Public: 30382903051367
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: 305136
• Device Catalogue Number: 305136
• Device Lot Number: 8228979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 12/02/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2018
• 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