MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 5 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 04/09/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: unknown.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can¿t be determined as no samples were received.Examination of the product involved may provide clarification as to the cause for the reported failure.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.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.This is the 1st complaint for lot # 8331767 for this type of defect or symptom.

Event Description

It was reported that during use the barrel was discovered to be cracked with a 5 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, translated from chinese to english: the patient was admitted for treatment due to lumbago and leg pain.On (b)(6) 2020, the nurse found a crack on the barrel when using the prefilled catheter.The new flush was immediately replaced and continued to be used, there was no other situation for this patient.

• Brand Name: 5 ML 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: 9965970
• MDR Text Key: 188403293
• Report Number: 1911916-2020-00383
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903096572
• UDI-Public: 00382903096572
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2020

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 306594
• Device Lot Number: 8331767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• 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