MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR¿ FILTER NEEDLE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Catalog Number 305200

Device Problem Contamination (1120)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

It was reported that a piece of the vial stopper fell into the syringe after the bd nokor¿ filter needle was used to puncture through it.The following information was provided by the initial reporter: "last week our emergency room had an incident of a particle of the vial stopper getting into the syringe and now don¿t want to use them.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Manufacturer Narrative

H6: investigation summary: it was reported a particle of the vial stopper got into the syringe.To aid in the investigation, one sample connected to a 3ml syringe, an empty vial and one photo were received for evaluation by our quality team.The sample came with the plastic shield, but no packaging blister.The needle tip was visually inspected with a 30x microscope.There was no damage, defective grind or hooks observed.The etch of the needle was good.The syringe has 2ml of a drug.Inside the syringe there is a piece of material similar to the color of the vial stopper about 1/16" in size that is floating in the solution.It could be possible to coring defect could occur if the composition of the stopper vial material is soft.The needle tip has no conditions that could induce the damage.The photo provided shows the sample received.As the lot number provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the returned sample analysis the symptom reported by the customer of particle of the vial stopper is confirmed.However, it is not confirmed as a coring needle as the needle has no defects.

Event Description

It was reported that a piece of the vial stopper fell into the syringe after the bd nokor¿ filter needle was used to puncture through it.The following information was provided by the initial reporter: "last week our er had an incident of a particle of the vial stopper getting into the syringe and now don¿t want to use them.".

• Brand Name: BD NOKOR¿ FILTER NEEDLE
• Type of Device: MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
• 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: 16200636
• MDR Text Key: 309017847
• Report Number: 1911916-2023-00005
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382903052004
• UDI-Public: 00382903052004
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/07/2023

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 Catalogue Number: 305200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2022
• Initial Date FDA Received: 01/19/2023
• Supplement Dates Manufacturer Received: 02/07/2023
• Supplement Dates FDA Received: 02/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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