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

Catalog Number 306575

Device Problems Material Separation (1562); Device Displays Incorrect Message (2591)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a photo was provided for evaluation.The photo provided shows a syringe with an unassembled plunger rod, therefore failure mode is verified.The barrel has the stopper at 2.75 ml of the scale and the syringe has 2.75ml of blood.The syringe is one time use and it is expected that after flushing the saline solution the syringe is disposed.It shouldn¿t be used to pull out blood.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.Investigation conclusion: this is the first complaint for the lot# 8107872 for the same defect or symptom.There was no documentation of issues for the complaint of batch 8107872 during this production run.Root cause description: the syringe is one time use, and it is expected that after flushing the saline solution the syringe is disposed; it shouldn¿t be used to pull out blood.

Event Description

It was reported that a bd posiflush¿ sp syringe had plunger error when the rubber stopper separated from the plunger rod during use.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 that a bd posiflush sp syringe had plunger error when the rubber stopper separated from the plunger rod during use.There was no report of exposure, serious injury or medical intervention.

• Brand Name: BD POSIFLUSH¿ SP SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7794019
• MDR Text Key: 117724087
• Report Number: 1911916-2018-00451
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 09/17/2018

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: No Information
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 306575
• Device Lot Number: 8107872
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 07/30/2018
• Supplement Dates FDA Received: 09/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other