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

Catalog Number 306547

Device Problems Leak/Splash (1354); No Flow (2991)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ sp saline syringe had difficult plunger movement causing leakage.The following information was provided by the initial reporter: rcc received a complaint via email.Email(s) attached.Customer have had multiple reports of the 10ml bd flushes, ref 306547, that have been difficult to expel air from and causing occlusion alarms on our syringe pumps.Customer is waiting on the unit to get the lot number of the syringes and will forward bd that information.A reported lot number is 3207548.I have several of these at my desk currently and have been able to recreate the occlusion when these are placed on the pump.I have not had the issue with two other lots that i have tested.When i attempted to hand push the air out of the affected syringe, it was extremely difficult and caused the saline to shoot out of the syringe.I placed this syringe on the pump and ran it at 0.5 ml/hr and received no occlusion alarm.However, when i increased the rate to 3.0 ml per hour, the pump almost immediately alarmed.This was free flow at the patient end, so no patient occlusion was possible.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer 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.

Event Description

It was reported that the bd posiflush¿ sp saline syringe had difficult plunger movement causing leakage.The following information was provided by the initial reporter: rcc received a complaint via email.Customer have had multiple reports of the 10ml bd flushes, ref 306547, that have been difficult to expel air from and causing occlusion alarms on our syringe pumps.Customer is waiting on the unit to get the lot number of the syringes and will forward bd that information.A reported lot number is 3207548.I have several of these at my desk currently and have been able to recreate the occlusion when these are placed on the pump.I have not had the issue with two other lots that i have tested.When i attempted to hand push the air out of the affected syringe, it was extremely difficult and caused the saline to shoot out of the syringe.I placed this syringe on the pump and ran it at 0.5 ml/hr and received no occlusion alarm.However, when i increased the rate to 3.0 ml per hour, the pump almost immediately alarmed.This was free flow at the patient end, so no patient occlusion was possible.

Manufacturer Narrative

H6: investigation summary: it was reported flushes are difficult to expel air from and cause occlusion alarms on syringe pumps.To aid in the investigation, six empty samples with no 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 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 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¿ 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17795406
• MDR Text Key: 324029154
• Report Number: 1911916-2023-00680
• Device Sequence Number: 1
• Product Code: NGT
• 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: 09/27/2023

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: 3207548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/21/2023
• Supplement Dates Manufacturer Received: 09/26/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1