MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD; INTRAVASCULAR CATHETER

Catalog Number 306499

Device Problem Inappropriate Audible Prompt/Feedback (2280)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that 5 syr 10 ml fil saline shortlength plunger rods experienced a syringe pump alarm during use.The following information was provided by the initial reporter: material no.: 306499 , batch no.: unknown.Customer is having issues with bd syringe.The syringe is causing occlusion alarms within the syringe pump.

Manufacturer Narrative

H.6.Investigation summary: no samples displaying the condition reported are available for examination, so we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.H3 other text : see section h.10.

Event Description

It was reported that 5 syr 10 ml fil saline shortlength plunger rods experienced a syringe pump alarm during use.The following information was provided by the initial reporter: material no.: 306499; batch no.: unknown.Customer is having issues with bd syringe.The syringe is causing occlusion alarms within the syringe pump.

• Brand Name: SYR 10 ML FIL SALINE SHORTLENGTH PLUNGER ROD
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8906529
• MDR Text Key: 160322165
• Report Number: 1911916-2019-00835
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: 00382903064991
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 306499
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/19/2019
• Supplement Dates Manufacturer Received: 08/02/2019
• Supplement Dates FDA Received: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other