MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that the plunger did not fully advance while using 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter: failure to fully advance syringe plunger.

Manufacturer Narrative

Investigation summary: it was reported the syringe plunger would not fully advance.As a sample was not returned, a thorough sample investigation could not be completed.It could be possible that the customer is getting some products that are towards the high specification limit and are related to the symptom reported by the customer since they require extra force than normal to expel the solution.A device history record review was completed for provided material number 306546, lot number 2021612.Previous investigations have revealed that improper silicone application within the syringe barrel can create plunger resistance.Several quality initiatives have been implemented on our manufacturing line to ensure that the silicone application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the silicone is uniformly applied to the syringe barrel.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

• Brand Name: 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer (Section G): BECTON DICKINSON AND COMPANY; 2153 12th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14349572
• MDR Text Key: 291832517
• Report Number: 1911916-2022-00249
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065462
• UDI-Public: 00382903065462
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 2021612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2022
• 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 Sex: Male