MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 TOOMEY IRRIGATION SYRINGE 70ML WITH CATHETER TIP AND LUER TIP ADAPTERS, PLASTIC,

Catalog Number 0038460

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed.The device was not returned for evaluation.A potential failure mode could be "toomey adapter detaches from tip of syringe." a potential root cause for this failure could be"-dimensions of syringe or adapter toomey out to specification." the lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "70cc syringe with catheter tip and luer tip adapters toomey syringe three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation catheter tip - for catheter irrigation 1 luer adapter (for foley catheter inflation) warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Bard is a trademark and/or registered trademark of c.R.Bard, inc.Copyright ©2012 c.R.Bard, inc.All rights reserved.This is a single use device.Do not re-sterilize any portion of this device.Do not use if package is damaged.Use by caution, consult accompanying documents.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.Catalog number lot number units manufacturer authorized representative in the european community sterilized using ethylene oxide.Assembled in mexico single use do not resterilize latex free".

Event Description

It was reported that the tip of the toomey irrigation syringe detached during use.No patient injury reported.

• Brand Name: TOOMEY IRRIGATION SYRINGE 70ML WITH CATHETER TIP AND LUER TIP ADAPTERS, PLASTIC,
• Type of Device: TOOMEY IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8875271
• MDR Text Key: 188347680
• Report Number: 1018233-2019-04571
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049316
• UDI-Public: (01)00801741049316
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/08/2019

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: Health Professional
• Device Catalogue Number: 0038460
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 08/08/2019
• 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