MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD LUER-LOK TIP SYRINGE; PISTON SYRINGE

Model Number 302830

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was completed by our quality engineer team for provided material number 302830 and lot number 0338634.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.Further action has not been determined necessary at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd luer-lok¿ tip syringe plunger was difficult to move while in the patient's vein.The following information was provided by the initial reporter: "the plunger sticks when filled and they are sure they are in the vein but they feel resistance on the plunger.They have to insert another i.V to the patient.".

• Brand Name: BD LUER-LOK TIP SYRINGE
• Type of Device: PISTON SYRINGE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12713029
• MDR Text Key: 278834442
• Report Number: 1911916-2021-01114
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903028307
• UDI-Public: 30382903028307
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/30/2021

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 Model Number: 302830
• Device Catalogue Number: 302830
• Device Lot Number: 0338634
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2020
• 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