MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH 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 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the plunger on the bd posiflush¿ prefilled normal saline flush syringe was difficult to move.Report 2 of 2.The following was received from the initial reporter: pharmacist called to report that there have been 2 occurrences of the plunger being difficult to move.1st on (b)(6) 2023 (lot# 3090870) and again on (b)(6) 2023 (lot# 3090870).There was no patient impact.

Event Description

It was reported that the plunger on the bd posiflush¿ prefilled normal saline flush syringe was difficult to move.Report 2 of 2.The following was received from the initial reporter: pharmacist called to report that there have been 2 occurrences of the plunger being difficult to move.1st on (b)(6) 2023 (lot# 3090870) and again on (b)(6) 2023 (lot# 3090870).There was no patient impact.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 18-sep-2023.H6: investigation summary: it was reported the plunger is difficult to move.To aid in the investigation, two empty samples with no packaging flow wrap, or tip cap, and one photo was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.The photo provided shows one of the samples received.A device history record review was completed for provided material number 306546, lot 3090870.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.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 determined.

• Brand Name: BD POSIFLUSH¿ PREFILLED NORMAL SALINE FLUSH 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17815784
• MDR Text Key: 324222926
• Report Number: 1911916-2023-00686
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 3090870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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