MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 03/09/2020

Event Type  malfunction  

Manufacturer Narrative

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 a cracked barrel was found before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "bd research and development called to report two syringes being crack on the plastic.The customer works for bd." 2 occurrences were reported.

Manufacturer Narrative

H.6 investigation summary.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.However, it could have happened a jam at the diverter; inducing a damage to the barrel.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 # 9317070 for this type of defect or symptom.There was no documentation for this type of defect during the entire production run of this batch.H3 other text : see h.10.

Event Description

It was reported that a cracked barrel was found before use with a 10 ml bd posiflush¿ normal saline syringe.The following information was provided by the initial reporter, "bd research and development called to report two syringes being crack on the plastic.The customer works for bd." 2 occurrences were reported.

• Brand Name: 10 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
• MDR Report Key: 9908151
• MDR Text Key: 187050816
• Report Number: 1911916-2020-00322
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

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: Other
• Device Expiration Date: 10/31/2022
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 9317070
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/31/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other