MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE FLUSH

Catalog Number 306547

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/29/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.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¿ normal saline syringe broke off in arterial line transducer.No injury.Happens when the nurses are monitoring blood pressure.When they have to zero out the line, they hook a saline syringe up to the end to keep it primed.Reported during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.Device history record review could not be performed because the lot number is unknown.This complaint will be entered into the complaint management system and will be tracked & trended for future occurrences.Root cause is undetermined.As no sample, lot, or batch was provided, no formal corrective action is necessary.

• Brand Name: BD POSIFLUSH¿ NORMAL SALINE SYRINGE
• Type of Device: SALINE FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 7342180
• MDR Text Key: 102731324
• Report Number: 1911916-2018-00092
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• PMA/PMN Number: K141311
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 306547
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other