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

Catalog Number 306547

Device Problem Material Deformation (2976)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported that the bd posiflush¿ normal saline syringe was damaged.The following information was provided by the initial reporter: the white hub in the end of the syringe appears squished and bent a little.Also brownish discoloration/mark on the white hub/cap is visible.Issues identified before product packaging was opened.

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 16-oct-2023.H6: investigation summary it was reported the white hub at the end of the syringe appears squished and bent with a brownish discoloration.To aid in the investigation, one sample in a sealed packaging flow wrap and one photo was provided for evaluation by our quality team.A visual inspection was performed, and the syringe tip cap is damaged and has a brown stain.The photo provided shows the sample received.No other defects or imperfections were observed.This defect could occur if the unit was not placed properly on the sterilization fixture.A device history record review was completed for provided material number 306547, lot 3090894.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

Event Description

It was reported that the bd posiflush¿ normal saline syringe was damaged.The following information was provided by the initial reporter: the white hub in the end of the syringe appears squished and bent a little.Also brownish discoloration/mark on the white hub/cap is visible.Issues identified before product packaging was opened.

• Brand Name: 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
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17908774
• MDR Text Key: 325393652
• Report Number: 1911916-2023-00757
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065470
• UDI-Public: (01)30382903065470
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K161552
• 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: 10/17/2023

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 Catalogue Number: 306547
• Device Lot Number: 3090894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 10/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2023
• 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