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

Catalog Number 0038460

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that a hair was found inside of the syringe prior to use.

Manufacturer Narrative

The reported event was confirmed.Visual inspection noted 3 photo samples received each depicting a syringe in opened packaging.Visual evaluation noted a large piece of hair in the end of the syringe barrel in two of the photos.This is a confirmed failure per the standard stating, no hair in product is permitted.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be defective/ contaminated components from supplier.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and 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.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 released" h11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that a hair was found inside of the syringe prior to use.

• Brand Name: TOOMEY IRRIGATION SYRINGE 70ML WITH CATHETER TIP AND LUER TIP ADAPTERS, PLASTIC,
• Type of Device: TOOMEY SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9764185
• MDR Text Key: 184650162
• Report Number: 1018233-2020-01399
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741049316
• UDI-Public: (01)00801741049316
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0038460
• Device Lot Number: NGDT3049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Date Manufacturer Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1