MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE

Catalog Number 306595

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 12/07/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: two samples were received for evaluation.A visual inspection was performed finding none of the reported defects.The tip cap looks clean and the solution has no foreign matter or anything abnormal, the inspection was also performed using a 10x magnifier lens.The second syringe received an inspection using a 10x magnifier lens finding everything normal, no defects were observed.Additionally, two photos were provided.One photo shows a brown stain on the tip cap and the other photo shows a syringe with similar brown stain on the barrel therefore failure mode is verified.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: this is the first complaint for lots # 8019839 for this type of defect or symptom.There was no documentation of issues for the complaint of lots # 8019839 during this production run.Root cause description: root cause is unknown based on the photo evaluation.

Event Description

It was reported that there were "turbid suspensions" inside the bd posiflush¿ normal saline syringe, and the cap and solution were "contaminated".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: 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 ; 8015652845
• MDR Report Key: 8201288
• MDR Text Key: 131607648
• Report Number: 1911916-2018-00780
• Device Sequence Number: 1
• Product Code: FMF
• 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,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/11/2018

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: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 306595
• Device Lot Number: 8019839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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