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

Catalog Number 30654778

Device Problem Break (1069)

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

Event Date 01/31/2023

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd posiflush¿ iv flush solution sodium chloride the tip of the syringe broke off.There was no report of patient impact.The following information was provided by the initial reporter: syringe tip broke off in tubing.

Event Description

It was reported while using bd posiflush¿ iv flush solution sodium chloride the tip of the syringe broke off.There was no report of patient impact.The following information was provided by the initial reporter: syringe tip broke off in tubing.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09mar2023.H6: investigation summary it was reported the syringe tip broke off in tubing.To aid in the investigation, one empty sample with no packaging flow wrap and three photos were provided for evaluation by our quality team.Together with the syringe, an extension tubing also was received.A visual inspection was performed.The syringe barrel tip is missing and is at the extension tubing connector.No other defects or imperfections were observed.The three photos provided show the sample received.This damage could occur to any syringe during connection with over torquing.A device history record review was completed for provided material number 30654778, lot 2311580.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.H3 other text : see h10.

• 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 ; 8448235433
• MDR Report Key: 16499197
• MDR Text Key: 310858372
• Report Number: 1911916-2023-00123
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065479
• UDI-Public: 00382903065479
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 30654778
• Device Lot Number: 2311580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2022
• 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