MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306547

Device Problem Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 09/07/2023

Event Type  malfunction  

Event Description

It was reported while using bd posiflush¿ normal saline syringe, in 10 ml syringe the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer had 100% failure when trying to run this lot number on an iv pump.Running these on a iv syringe pump is an essential use of these, especially in the nicu.Customer have had several reports of occlusions with these syringes.It seems the plunger is sticking causing the pump to alarm occluded rendering the syringe unable to be administered.

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ normal saline syringe, in 10 ml syringe the needle was clogged.There was no report of patient impact.The following information was provided by the initial reporter: customer had 100% failure when trying to run this lot number on an iv pump.Running these on a iv syringe pump is an essential use of these, especially in the nicu.Customer have had several reports of occlusions with these syringes.It seems the plunger is sticking causing the pump to alarm occluded rendering the syringe unable to be administered.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 16-oct-2023.H6: investigation summary: it was reported the plunger is sticking causing the pump to alarm occluded.To aid in the investigation, six samples were received for evaluation by our quality team.Five samples came in sealed packaging flow wraps, and one came with no packaging flow wrap or tip cap.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.A device history record review was completed for provided material number 306547, lot 3207548.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 determined.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE, IN 10 ML 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: 17822160
• MDR Text Key: 324332038
• Report Number: 1911916-2023-00689
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• 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: 10/10/2023

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 Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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