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

Catalog Number 309653

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 03/17/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.Investigation summary: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Examination of the product involved may provide clarification as to the cause for the reported failure.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 became stuck while infusing metaraminol in a syringe driver.This occurred with 2 syringes during use.The following information was provided by the initial reporter: "my name is customer x and i¿m the icu equipment nurse at x.Recently i had a problem with a couple of bd plastipak 60ml syringes.Both of them had the same problem in that the plunger became stuck whilst infusing metaraminol in a syringe driver at 2ml/hour.I haven¿t come across this before and i¿ve tried a couple of syringes today without an issue.Initially the pump was alarming occlusion but in troubleshooting the problem i was unable to aspirate the syringe without using a lot of force.I changed the syringe and the same problem occurred.The pump rep was in the hospital the following day and referred to this problem as ¿stiction¿ ¿ i hadn¿t come across this term before.".

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16678650
• MDR Text Key: 313561660
• Report Number: 1911916-2023-00203
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903096534
• UDI-Public: 00382903096534
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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