MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; N/A

Catalog Number 306575

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one sample was received.It has no packaging flow wrap.It has the plunger rod-rubber stopper, the tip cap and saline solution.It has the luer tip bent.This occurs when the syringe is misplaced in the sterilizer tray the next tray that goes on top lays on top of the misplaced syringe inducing the damage of the luer tip.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.Investigation conclusion: 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.Root cause description: it occurred during the sterilizer tray loading process.Rationale: capa not required at this time.

Event Description

It was reported that 10 ml bd posiflush¿ sp pre-filled flush syringe nacl 0.9% tip was bent.This was discovered before use.The following information was provided by the initial reporter: bent tip.

• Brand Name: 10 ML BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• Type of Device: N/A
• 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: 9875639
• MDR Text Key: 187055656
• Report Number: 1911916-2020-00295
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/11/2020

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: 07/31/2022
• Device Catalogue Number: 306575
• Device Lot Number: 9212795
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2020
• Initial Date FDA Received: 03/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• 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