MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306595

Device Problems Break (1069); Fluid/Blood Leak (1250); Physical Property Issue (3008)

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

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the bd posiflush¿ normal saline syringe there was an issue with the barrel/flange being damaged.It was stated ¿the nurse found the flange/barrel broken and the solution leaked when the unit package was opened before use.¿ there was no report of injury or further 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: device returned to manufacture: yes.

Event Description

It was reported with the use of the bd posiflush normal saline syringe there was an issue with the barrel/flange being damaged.It was stated ¿the nurse found the flange/barrel broken and the solution leaked when the unit package was opened before use.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd posiflush¿ normal saline syringe there was an issue with the barrel/flange being damaged.It was stated ¿the nurse found the flange/barrel broken and the solution leaked when the unit package was opened before use.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: three (3) shelf boxes with products were received for evaluation by one or our quality engineers.The shelf box labels confirm the lot# 7208540.Total of 104 syringes were in the shelf boxes.Visual inspection was performed.50 syringes were good.47 had barrel flange damaged and 7 had cracked barrel therefore failure mode is verified.While root cause could not be definitively determined, it's possible that the plunger rod labeler equipment experienced a variation.Any adjustments made have been verified.A device history review was completed and there was no documentation of issues for the complaint of batch 7208540 during this production run.There were no quality notifications issued during the production of this batch listed in the complaint.Capa (b)(4) has been opened.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 POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7534377
• MDR Text Key: 108996423
• Report Number: 1911916-2018-00255
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306595
• Device Lot Number: 7208540
• Date Manufacturer Received: 05/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other