MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 305129

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd¿ needle 2 in.Single use, sterile, 21 g foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: there appears to be a white substance in the barrel of some of these needles that is not normally present.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 06-jan-2023.H6: investigation summary it was reported that there is a white substance on the needle.To aid in the investigation, forty-four samples and seven photos were provided for evaluation by our quality team.Forty-two samples came in sealed packaging blisters and two came with no packaging.Each sample has the plastic shield.A visual inspection was performed.Three samples have an epoxy drip over on the needle hub.In the photos provided, two photos show a certificate of compliance.Three photos show a needle assembly with no defects or imperfections.The other two photos show a needle assembly with an epoxy drip over on the needle hub.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 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 hub.A device history record review was completed for provided material number 305129, lot number 0202355.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.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

Event Description

It was reported while using bd¿ needle 2 in.Single use, sterile, 21 g foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: there appears to be a white substance in the barrel of some of these needles that is not normally present.

Event Description

It was reported while using bd¿ needle 2 in.Single use, sterile, 21 g foreign matter was found in the fluid pathway.There was no report of patient impact.The following information was provided by the initial reporter: there appears to be a white substance in the barrel of some of these needles that is not normally present.

Manufacturer Narrative

It was reported there is a white substance on the needle.To aid in the investigation, seven photos were provided for evaluation by our quality team.Two photos show a certificate of compliance.Three photos show a needle assembly with no defects or imperfections.The other two photos show a needle assembly with an epoxy drip over on the needle hub.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 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 hub.A device history record review was completed for provided material number 305129, lot number 0202355.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.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

• Brand Name: BD¿ NEEDLE 2 IN. SINGLE USE, STERILE, 21 G
• Type of Device: 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: 16039785
• MDR Text Key: 308281487
• Report Number: 1911916-2022-00771
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2023

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
• Device Operator: Other
• Device Model Number: 305129
• Device Catalogue Number: 305129
• Device Lot Number: 0202355
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/04/2023; 01/12/2023
• Supplement Dates FDA Received: 01/10/2023; 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1