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

Catalog Number 306547

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.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 4 bd posiflush¿ sp saline syringes had difficult plunger movement during the flush.The following information was provided by the initial reporter: "i have 4+ cases of reference# (b)(4) (lot# 2237672) that we removed from inventory due to complaints of the syringe sticking when administering the flush.I happened on multiple occasions and all instances where linked to this lot number.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 10aug2023.H6: investigation summary it was reported the syringe sticks when administering the flush.To aid in the investigation, nine samples in sealed packaging flow wraps were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was tested for sustaining force per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.A device history record review was completed for provided material number 306547, lot 2237672.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.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.

Event Description

It was reported that 4 bd posiflush¿ sp saline syringes had difficult plunger movement during the flush.The following information was provided by the initial reporter: "i have 4+ cases of ref# 306547 (lot# 2237672) that we removed from inventory due to complaints of the syringe sticking when administering the flush.I happened on multiple occasions and all instances where linked to this lot number.".

• Brand Name: BD POSIFLUSH¿ SP 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: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17385898
• MDR Text Key: 320230756
• Report Number: 1911916-2023-00509
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• 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,Followup
• Report Date: 08/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306547
• Device Lot Number: 2237672
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2022
• 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