MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED NORMAL SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306593

Device Problem Defective Component (2292)

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

Event Date 06/01/2023

Event Type  malfunction  

Manufacturer Narrative

H.6.Investigation summary: it was reported the plunger rod was damaged.To aid in the investigation, one empty sample with no packaging flow wrap was received for evaluation by our quality team.A visual inspection was performed, and the top part of the plunger rod is damaged.No other defects or imperfections were observed.This defect could occur if the unit was not properly spaced while being flow wrapped.When the flow wrap cutter went the cut the packaging, the plunger rod could have been damaged.A device history record review was completed for provided material number 306593, lot 2096905.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.The sample will be shown to associates for awareness.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.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported while using bd pre-filled normal saline syringe the plunger was damaged.There was no report of patient impact.The following information was provided by the initial reporter, translated from chinese to english: in the international medical department, when the product package was opened, the injection rod was found to be damaged.1 sample can be returned (the other has been discarded).

• Brand Name: BD PRE-FILLED 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17209992
• MDR Text Key: 317943680
• Report Number: 1911916-2023-00430
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065936
• UDI-Public: (01)00382903065936
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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
• Report Date: 06/08/2023

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: 306593
• Device Lot Number: 2096905
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2022
• 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