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

Catalog Number 306594

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/11/2019

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 first complaint for the lot# 8050911 for the same defect or symptom.There was no documentation of issues for the complaint of batch #(b)(4) during the production run.Root cause description : undetermined.

Event Description

It was reported that a bd posiflush¿ syringe had a loose cap.Foreign complaints the following information was provided by the initial reporter, translated from chinese to english: ¿ before using, it was found the cap loose.Replacing a new flush to solve the issue ¿.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: FLUSH SYRINGE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8487144
• MDR Text Key: 141195324
• Report Number: 1911916-2019-00354
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2019

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: 02/28/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8050911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2018
• 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