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

Model Number 306546

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2115276.Medical device expiration date: 30-apr-2025.Device manufacture date: 25-apr-2022.Medical device lot #: 2115277.Medical device expiration date: 30-apr-2025.Device manufacture date: 25-apr-2022.Medical device lot #: 1167960.Medical device expiration date: 30jun2024.Device manufacture date: 16jun2021.Medical device lot #: 1116327.Medical device expiration date: 30apr2024.Device manufacture date: 26apr2021.Medical device lot #: 2045306.Medical device expiration date: 28feb2025.Device manufacture date: 14feb2022.Investigation summary: it was reported there was resistance when attempting to push the plunger to flush a line.To aid in the investigation, two empty samples with no packaging flow wraps or tip caps were received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The samples were then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the results were within specification.A device history record review was completed for provided lot numbers.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.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.

Event Description

It was reported that bd posiflush¿ normal saline syringes had difficult plunger movement during the flush.The following information was provided by the initial reporter: "3 instances in which end-user encountered resistance when attempting to push plunger to flush line.".

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16356361
• MDR Text Key: 309474322
• Report Number: 1911916-2023-00065
• 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: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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