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

Model Number 306546

Device Problems Complete Blockage (1094); Failure to Deliver (2338)

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

Event Date 01/04/2022

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: material no: 306546 batch no: 1229152 it was reported that the syringes used by the health professional is having some kind of pressure build up where they no longer allow them to push the fluid into the vein.

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2022-01-25 h5: imdrf annex a grid: a140901.H6: investigation summary to aid in the investigation of this issue, twelve physical samples were returned for evaluation by our quality engineer team.The samples were inspected and two of the samples displayed signs of plunger movement difficulty.Based on the investigation results, this issue most likely resulted from an error with the siliconization units and an incorrect dose of silicon was applied to the barrel.A device history record review was completed for provided lot number 1229152.The review identified one non-conformance that could have been associated with this issue.There was an intermittent issue during production involving dry barrels; however, the issue was resolved at the time of occurrence.All product associated with the issue was held for inspection and any affected material was scrapped.For this incident to have occurred, it is possible that a limited amount of product went outside the contained material.A corrective and preventive action plan (capa) 3560615 has been raised 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.H3 other text : see h10.

Event Description

It was reported while using bd posiflush¿ normal saline syringes the plunger was difficult to move.There was no report of patient impact.The following information was provided by the initial reporter: material no: 306546 batch no: 1229152.It was reported that the syringes used by the health professional is having some kind of pressure build up where they no longer allow them to push the fluid into the vein.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGES,
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13338020
• MDR Text Key: 286152150
• Report Number: 9616657-2022-00001
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

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 Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1229152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2022
• Initial Date FDA Received: 01/24/2022
• Supplement Dates Manufacturer Received: 02/08/2022
• Supplement Dates FDA Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• 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