MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; INTRAVASCULAR CATHETER

Catalog Number 306546

Device Problem Flushing Problem (1252)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

958 samples were received by our quality team for evaluation.Upon visual inspection, they were in one full case box (480) 8 shelf boxes (240) and the rest came as bulk in a carton box, all have the sealed packaging flow wrap.Sustaining force testing was performed on a random sample of (b)(4) units, eight seven met specification limits and there were three that were out of specification limits.In addition, silicone dispersion testing was performed on (b)(4) units finding two samples showing limited amount of silicone was applied to the barrel.A device history record review found no non-conformances associated with this issue during production of this batch.Based upon the quality team's investigation, the root cause of this incident is related to not enough silicone applied to the barrel during the manufacturing process.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that during use of the 10 ml bd posiflush¿ normal saline syringe the syringe is no flushing completely "they are meeting resistance after about 5ml." the following information was provided by the initial reporter: 306546 specifically lot #8351551 not flushing completely.They are meeting resistance after about 5ml.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• 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: 8544974
• MDR Text Key: 145512074
• Report Number: 1911916-2019-00406
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/03/2019

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: 11/30/2021
• Device Catalogue Number: 306546
• Device Lot Number: 8351551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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