MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 TOOMEY IRRIGATION SYRINGE; TOOMEY SYRINGE

Catalog Number 0038460

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Information (3190)

Event Date 03/16/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that dr.(b)(6) was using the toomey and tried to connect a device to the toomey as he has in the past, however, it was allegedly loose.The apparent loose state meant that the toomey could not be used as a suction device.The nurses tried several other toomeys but allege the same thing happened.The representative, (b)(6), also tried three different toomeys and found the same thing.The toomey syringe was allegedly being used during a turp procedure to suction out chips from the prostate.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Manufacturer Narrative

Received 2 unopened toomey syringes in the original unit packaging.Visual inspection noted no obvious defects.The following functional evaluation was performed: fill the syringe with 70cc water.Hold the syringe.During the test, it was found that the syringes did not hold water as the plunger slipped through the barrel.A dimensional evaluation found that the inner barrel was within specifications however the outer barrel was found to be out of specifications.The complaint was confirmed as a supplier related issue.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "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." (b)(4).

• Brand Name: TOOMEY IRRIGATION SYRINGE
• Type of Device: TOOMEY SYRINGE
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5565677
• MDR Text Key: 42949137
• Report Number: 1018233-2016-00453
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 0038460
• Device Lot Number: NGZF4488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2015
• 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