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

Catalog Number 302827

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported during storage that the bd luer-lok¿ syringe had "a problem in the sealing of the packages".Found before use.No serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: four samples were returned for evaluation.The samples provided had no seal therefore failure mode was verified.Samples were analyzed by the department technical personnel.It was determined that the no seal defect was likely caused by an operator accidently opening a door or pressing an emergency stop on the packaging machine during the packaging process.If the packager is stopped during the sealing process, the seal gasket can stick to the web.When the machine is restarted, the web will pull the seal gasket out of the seal station and cause the following packages to not have seals.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the first complaint for the lot# 7282553 for the same defect or symptom.No related defects or qns were recorded in the dhr.A formal corrective action will not be initiated as the defect rate is within allowed quality limits.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported during storage that the bd luer-lok¿ syringe had "a problem in the sealing of the packages".Found before use.No serious injury or medical intervention reported.

• Brand Name: BD LUER-LOK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7654868
• MDR Text Key: 113003924
• Report Number: 1911916-2018-00352
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 302827
• Device Lot Number: 7282553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Initial Date Manufacturer Received: 06/11/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 06/11/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other