MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE; SALINE, VASCULAR ACCESS FLUSH

Model Number 306546

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/18/2021

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 the bd posiflush¿ iv flush solution sodium chloride had a deformed tip cap.The following information was provided by the initial reporter: the customer complained that the white tip cap was found deformed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/17/2021.H.6.Investigation: it was reported the white tip cap was found deformed.To aid in the investigation, one sample in a sealed packaging flow wrap and two photos were provided for evaluation by our quality team.A visual inspection was performed and the tip cap is damaged.No other defects or imperfections were observed.This defect could occur if when loading the syringe in the sterilization tray it was misplaced and damaged when the next sterilization tray was put on top.The photos provided show the sample received.A device history record review was completed for provided material number 306546, lot number 1082924.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.Verification of the sterilization loading process was performed.The settings were correct and products were being placed correctly.Based on the investigation and with the sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that the bd posiflush¿ iv flush solution sodium chloride had a deformed tip cap.The following information was provided by the initial reporter: the customer complained that the white tip cap was found deformed.

• Brand Name: BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13060509
• MDR Text Key: 286353301
• Report Number: 1911916-2021-01284
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: 30382903065463
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K003553
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 1082924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2021
• Initial Date FDA Received: 12/22/2021
• Supplement Dates Manufacturer Received: 01/05/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2021
• 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