MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Short Fill (1575)

Patient Problem Air Embolism (1697)

Event Date 07/20/2023

Event Type  Injury  

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 bd pre-filled saline syringe was near empty.The following was received by the initial reporter: verbatim: reported an issue regarding bd posiflush xs (product code: 306572, batch: 3047847).It was stated that patient had some issues with the pre-filled syringes.Patient took one and flushed on hickman line hen realized that the syringes was near enough empty with only 3ml saline.Patient pushed air in which could have been fatal and had to be taken to a&e and monitored for the whole day incase of embolism.

Manufacturer Narrative

H6: investigation summary a device history record review was completed for provided material number 306572 and lot number 3047847.The review did not reveal any possible non-conformances that could have contributed to this reported issue.As neither physical samples or picture samples were available for return, a thorough sample analysis could not be completed.Based on the limited investigation results, an exact cause could not be determined for this event.

Event Description

It was reported that the bd pre-filled saline syringe was near empty.The following was received by the initial reporter: verbatim: reported an issue regarding bd posiflush xs (product code: 306572, batch: 3047847).It was stated that patient had some issues with the pre-filled syringes.Patient took one and flushed on hickman line hen realized that the syringes was near enough empty with only 3ml saline.Patient pushed air in which could have been fatal and had to be taken to a&e and monitored for the whole day incase of embolism.

• Brand Name: BD PRE-FILLED SALINE SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17477317
• MDR Text Key: 320573435
• Report Number: 9616657-2023-00031
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2023

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: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 3047847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/21/2023
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 09/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2023
• 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