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 Problems Defective Component (2292); Physical Resistance/Sticking (4012)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that 5 of the plungers on the bd posiflush¿ prefilled normal saline flush syringe was difficult to move.This is report 2 of 2.The following was received by the initial reporter: customer having trouble pushing out fluids in lot# 3103219 -10 ml prefilled syringes.Response received on 30-aug-2023.We first had an event on (b)(6) 2023.It was discovered while flushing a patient iv.There was no harm to the patient.This was being done manually.There was no visible blockage.We had 6 events total with the same lot number.Essentially, the syringes were very hard to flush.You had to exert an unusual amount of pressure in order to push the fluid out.

Manufacturer Narrative

B.3.Date of event is unknown; awareness date has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

A device history record review was completed for provided material number 306546 and lot number 3103219.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, 132 physical samples were returned for evaluation by our quality engineer team.The samples were all loosely packed in a box with their original flow wrap packaging.Glide force testing was performed on all of the returned samples.Out of 132 samples tested, 17 failed the glide force testing; confirming the reported defect of plunger movement difficulty due to dry barrels.The most probable cause for the defective product was a faulty thermocouple, which was replaced earlier this year.The thermocouple controls the dispersion of silicone in the syringe barrel.The faulty thermocouple in turn led to intermittent defects which were not detected during the in-process checks.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Event Description

Response received on 30-aug-2023.We first had an event on 8/21.It was discovered while flushing a patient iv.There was no harm to the patient.This was being done manually.There was no visible blockage.We had 6 events total with the same lot number.Essentially, the syringes were very hard to flush.You had to exert an unusual amount of pressure in order to push the fluid out.

• 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): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17795590
• MDR Text Key: 324032262
• Report Number: 1911916-2023-00679
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K003553
• 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: 12/11/2023
• 2 Devices were Involved in the Event: 1 2

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 Catalogue Number: 306546
• Device Lot Number: 3103219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2023
• 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