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

Catalog Number 306544

Device Problem Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history review could not be completed as no batch number was provided.Investigation conclusion: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.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.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.Root cause description: no root cause can be determined as no samples were received.Undetermined rationale: no batch#/sample available.

Event Description

Material no: 306544, batch no: unknown.It was reported that during use of the bd posiflush¿ normal saline syringe the product creates too much pressure when administering medicine and causes the vein to burst.The following information was provided by the initial reporter: i just had a call from a pharmacy buyer looking for the status of material 306507, however this item is discontinued and refered her to the substitute.She said that the substitute, 306544, is causing issues for nicu patients did not want to use it.I have referred to sales rep as well.306507 ¿ customer used to use.306544 ¿ customer reported that the material creates too much pressure when administering medicine which causes the vein to burst on nicu patients.

• Brand Name: BD POSIFLUSH¿ NORMAL 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8647269
• MDR Text Key: 146984629
• Report Number: 1911916-2019-00524
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065449
• UDI-Public: 30382903065449
• 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
• Report Date: 05/14/2019

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: 306544
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2019
• Initial Date FDA Received: 05/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other