MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE CATHETER TIP 2OZ; IRRIGATING SYRINGE

Model Number 309620

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

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

Event Date 07/14/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.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 syringe catheter tip 2oz had plunger movement issues.The following information was provided by the initial reporter: ".We have to crush medical pills to add to 50 ml of water and apply to the feeding tube.These crushed pills added to the water in the syringe seem to affect the interior walls of the syringe making it extremely difficult to push the plunger.I can only use the syringe once.".

• Brand Name: SYRINGE CATHETER TIP 2OZ
• Type of Device: IRRIGATING 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: 12312072
• MDR Text Key: 266171764
• Report Number: 1911916-2021-00813
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 309620
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2021
• 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