MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; PRE-FILLED SYRINGE

Catalog Number 306594

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 03/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.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 1st complaint for lot # 8082847 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.Root cause description: undetermined.

Event Description

It was reported that during use of bd posiflush¿ syringe barrel/flange was broken.Discontinued use.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: PRE-FILLED 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: 8432310
• MDR Text Key: 139336728
• Report Number: 1911916-2019-00282
• 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: 03/11/2019

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: 03/31/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8082847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/07/2019
• Initial Date FDA Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2018
• 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