MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NOKOR¿ FILTER NEEDLE WITH 5-MICRON FILTER MEMBRANE; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE

Model Number 515064

Device Problem Contamination (1120)

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

Event Date 01/05/2023

Event Type  malfunction  

Manufacturer Narrative

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 nokor¿ filter needle with 5-micron filter membrane foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: foreign matter was observed within one filter needle.

Manufacturer Narrative

H6.Investigation summary: it was reported there was one filter needle with foreign matter.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a needle assembly with black specks in its packaging blister.From the photos, it is not clear if the specks are in the inner side or outer side of the packaging blister top web.No other information could be obtained from the photos.A device history record review was completed for provided material number 305200, lot 0310400.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but without the physical sample analysis a probable root cause could not be offered.

Event Description

It was reported while using bd nokor¿ filter needle with 5-micron filter membrane foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: foreign matter was observed within one filter needle.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 06-jun-2023.H6: investigation summary it was reported there was one filter needle with foreign matter.To aid in the investigation, one sample in a sealed packaging blister and two photos were provided for evaluation by our quality team.A visual inspection was performed with 10x magnification, and no defects or imperfections were observed.The photos show a needle assembly with black specks in its packaging blister.From the photos, it is not clear if the specks are in the inner side or outer side of the packaging blister top web.No other information could be obtained from the photos.A device history record review was completed for provided material number 305200, lot 0310400.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed but could not be confirmed with the physical sample analysis, and a probable root cause could not be offered.

Event Description

It was reported while using bd nokor¿ filter needle with 5-micron filter membrane foreign matter was found.There was no report of patient impact.The following information was provided by the initial reporter: foreign matter was observed within one filter needle.

• Brand Name: BD NOKOR¿ FILTER NEEDLE WITH 5-MICRON FILTER MEMBRANE
• 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: 16359732
• MDR Text Key: 309488128
• Report Number: 1911916-2023-00067
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 00382905150647
• UDI-Public: (01)00382905150647
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/12/2023

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: 515064
• Device Catalogue Number: 305200
• Device Lot Number: 0310400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2023
• Initial Date FDA Received: 02/11/2023
• Supplement Dates Manufacturer Received: 02/15/2023; 06/12/2023
• Supplement Dates FDA Received: 03/06/2023; 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2021
• 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