MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306547

Device Problem Disconnection (1171)

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

Event Date 01/11/2019

Event Type  malfunction  

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.Investigation conclusion: this is the third complaint for the lot# 8261706 for the same defect or symptom.Previous complaints: (b)(4).There was no documentation of issues for the complaint of batch 8261706 during this production run.Root cause description: undetermined.

Event Description

It was reported that the plunger on a 10 ml bd posiflush¿ normal saline syringe became disconnected from the rubber stopper.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8305837
• MDR Text Key: 135174628
• Report Number: 1911916-2019-00144
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: 30382903065470
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 306547
• Device Lot Number: 8261706
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other