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

Catalog Number 309620

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.(b)(6).Investigation summary: one photo was received for investigation by our quality team.Upon visualization of the photo, the photo shows a syringe with the tip broken off.A device history record (dhr) review was performed on the batch associated with this investigation (batch 8270710).The dhr review did not reveal any defects or issues reported and no quality notifications were issued.Based on the quality team's investigation, the root cause of this incident cannot be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the syringe catheter tip 2oz experienced cannula breakage.The following information was provided by the initial reporter: material no: 309620, batch no: 8270710.It was reported that the tip of the syringe broke off while the nurse was preparing it for use.Event description per customer's email states, i just wanted to let you know that we had an incident filed around usage of bd item #309620, which is 60ml toomey syringe.No harm came to the patient or the nurse.However, because a ticket was placed with risk management that department has asked me to forward the information to you and investigate if you have had similar incidents with this product.The tip of the syringe broke off as the nurse was preparing it.The nurse unfortunately did not retain the broken syringe but did take a picture of it.The syringe tip usually is way too sturdy for that to occur.The lot # appears to be 8270710.

• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 8541978
• MDR Text Key: 145243426
• Report Number: 1911916-2019-00405
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 30382903096207
• UDI-Public: 30382903096207
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 309620
• Device Lot Number: 8270710
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2019
• Initial Date FDA Received: 04/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2018
• 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
• Patient Outcome(s): Other