MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK SYRINGE PISTON SYRINGE

Catalog Number 301031

Device Problem Volume Accuracy Problem (1675)

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

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: a device history record review was completed by our quality engineer team for provided material number 301031 and lot number 1116962. The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification. As a sample was not returned, a thorough sample investigation could not be completed. Based on the investigation results, an exact cause for this incident could not be identified. Further action has not been determined necessary at this time. 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 Description

It was reported that 4550 bd luer-lok¿ syringes were missing the oz scale markings on them. The following information was provided by the initial reporter: "this syringe should have the oz marking. We did find out that we have been receiving without this marking since 2018. Unfortunately, we did not caught it. ".

• Brand Name: BD LUER-LOK SYRINGE
• Type of Device: PISTON SYRINGE
• 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: 12407333
• MDR Text Key: 270638791
• Report Number: 1911916-2021-00907
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 301031
• Device Lot Number: 1116962
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial