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

Model Number 306546

Device Problem Component Missing (2306)

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

Event Date 04/27/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3010631.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

Event Description

It was reported that the bd posiflush¿ normal saline syringe flush was missing cap on syringe luer end, still sealed in cellophane wrapper.The following information was provided by the initial reporter: "flush was missing cap on syringe luer end, still sealed in cellophane wrapper." additional info received on (b)(6) 2023.The date of the finding was one day prior to reporting to bd product complaints department, only one syringe was found and reported, it is unknown if other syringes were found and not reported.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16970477
• MDR Text Key: 316109804
• Report Number: 1911916-2023-00331
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 306546
• Device Catalogue Number: 306546
• Device Lot Number: 3010631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2023
• 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