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

Catalog Number 306574

Device Problem Volume Accuracy Problem (1675)

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

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: one sample was received.The sample has no barrel label.When the machine stops and re starts again it may have a missed the barrel label and escaped; there are no additional controls to detect it.At the plunger rod labeler process, we have a sensor which is challenged at the shift start.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.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: confirmed: bd was able to duplicate or confirm the customer's indicated failure mode with the sample provided.This is the 1st complaint for lot # 9051675 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: when the machine stops and re starts again it may have a missed the barrel label and escaped; there are no additional controls to detect it.At the plunger rod labeler process, we have a sensor which is challenged at the shift start.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that before use, the scale was observed to be missing on 2 separate bd posiflush¿ sp syringes.The following information was provided by the initial reporter: "scale missing.".

• Brand Name: BD POSIFLUSH¿ SP
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• 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: 9483271
• MDR Text Key: 195113572
• Report Number: 1911916-2019-01311
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 306574
• Device Lot Number: 9051675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2019
• 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