MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306575

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: a device history record review was completed for provided material number 306575 and lot number 0315224.The review did not reveal any detected quality issues during the production process that could have contributed to this reported defect.To aid in the investigation, two samples were received for evaluation by our quality team.The samples came in a plastic bag with no packaging flow wrap, or tip cap and the plunger rod - rubber stopper is at 3.5ml of the scale marking.A visual inspection was performed and no defects or imperfections were observed.Each sample was then tested for sustaining force and all results were within specification.Based on the investigation results, the samples received did not show the symptom reported by the customer and an exact cause for this incident could not be identified.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 4 bd posiflush¿ sp pre-filled flush syringes nacl 0.9% had difficult plunger movement during the flush.The following information was provided by the initial reporter: "nurse indicates upon connection to iv cannuala she was unable to flush.The plunger initially moved forward as per a normal function and become stuck and she was unable to resume flushing.".

• Brand Name: BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11321655
• MDR Text Key: 232847056
• Report Number: 1911916-2021-00117
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 306575
• Device Lot Number: 0315224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/10/2020
• 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