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

Catalog Number 309653

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 02/12/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 that the bd luer-lok¿ tip syringe used to draw up medication did not seal properly between the plunger and the syringe barrel, causing the medication to leak past the plunger.As reported by the customer, "2 additional incidences.Same issue and contact as below string.We now have 2 different lot # 8270763 and 8270800 that we have examples to send you (b)(6) - the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe.This is causing the medication to leak past the plunger.".

Event Description

It was reported that the bd luer-lok¿ tip syringe used to draw up medication did not seal properly between the plunger and the syringe barrel, causing the medication to leak past the plunger.As reported by the customer, "2 additional incidences.Same issue and contact as below string.We now have 2 different lot # 8270763 and 8270800 that we have examples to send you problem - the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe.This is causing the medication to leak past the plunger.".

Manufacturer Narrative

Correction: additional information was received from the customer via email.The following information has been updated: date of event: (b)(6) 2019.Initial reporter address 2: (b)(6).

Manufacturer Narrative

Investigation summary: one sample was received.Visual inspection was performed finding no defects.It was tested for leakage and it passed with no leakage noted, therefore failure mode is not verified.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.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 2nd complaint for the lot# 8270800 for the same defects or symptoms.Previous complaint (b)(4).There was no documentation of issues for the complaint of batch # 8270800 during this production run.

Event Description

It was reported that the bd luer-lok¿ tip syringe used to draw up medication did not seal properly between the plunger and the syringe barrel, causing the medication to leak past the plunger.As reported by the customer, "2 additional incidences.Same issue and contact as below string.We now have 2 different lot # 8270763 and 8270800 that we have examples to send you problem - the pharmacy is reporting that a 60ml syringe they are using to draw up medications are not sealing properly between the plunger and barrel of the syringe.This is causing the medication to leak past the plunger.".

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8391308
• MDR Text Key: 138254248
• Report Number: 1911916-2019-00238
• 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,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 309653
• Device Lot Number: 8270800
• Date Manufacturer Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other