MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Complete Blockage (1094)

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

Event Date 09/06/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary; to aid in the investigation of this issue, physical samples were returned for evaluation by our quality engineer team.Through examination of the samples, plunger movement difficulty was detected.A device history record review was completed for provided lot number 1139777.There was one intermittent issue with dry barrels during the production process; however, the issue was resolved at the time of detection.Product associated with this defect was held for inspection and any affected material was scrapped.It is possible that a limited occurrence of product went uncontained.A corrective and preventive action plan has been initiated to further investigate this issue and prevent its recurrence.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

It was reported when using the bd posiflush¿ normal saline syringe, the device experienced difficult plunger movement.The following information was provided by the initial reporter.The customer stated: since yesterday our saline flushes are not functioning correctly.When we push to flush, they stop mid-way through and cannot flush any further.

• Brand Name: BD POSIFLUSH NORMAL SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12583808
• MDR Text Key: 275003319
• Report Number: 9616657-2021-00086
• 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: K141311
• 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: 09/20/2021

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: Other
• Device Expiration Date: 04/30/2024
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1139777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2021
• Initial Date FDA Received: 10/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/19/2021
• 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