MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD¿ SYRINGE WITH BD LUER-LOK¿ TIP; PISTON SYRINGE

Catalog Number 309653

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Fda notified: the initial reporter also notified the fda on 06/25/2018 via medwatch # mw5077814.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 via medwatch that the bd¿ syringe with bd luer-lok¿ tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: no.

Event Description

It was reported via medwatch that the bd syringe with bd luer-lok tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.

Event Description

It was reported via medwatch that the bd¿ syringe with bd luer-lok¿ tip syringe was found to have excess lubricant.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 second complaint for the lot# 8054766 for foreign matter.Additionally, silicone weight testing is performed at the middle and end of every batch.Silicone weight tests for this batch all measured within specification.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.

• Brand Name: BD¿ SYRINGE WITH BD LUER-LOK¿ TIP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• MDR Report Key: 7698981
• MDR Text Key: 114681863
• Report Number: 1911916-2018-00378
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: 30382903096535
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/04/2018

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: 02/28/2023
• Device Catalogue Number: 309653
• Device Lot Number: 8054766
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/18/2018
• Supplement Dates Manufacturer Received: 06/25/2018; 06/25/2018
• Supplement Dates FDA Received: 08/21/2018; 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other