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
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Date of Event	07/18/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that there was a hair found inside the syringe upon opening of the packet.There was no reported patient injury.
Additional Manufacturer Narrative
The reported event was confirmed, as manufacturing-related.Visual evaluation of the returned sample noted one opened (within unsealed original packaging) unused toomey irrigation syringe.Visual inspection of the sample noted a long black hair between the syringe barrel and syringe plunger.A portion of the hair was protruding from the end of the syringe barrel.The hair was removed and measured to be approximately 3.4" in length.This particle exceeded the maximum allowable foreign material threshold, therefore the syringe was considered to be out of specification.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: ¿70cc syringe with catheter tip and luer tip adapters this is a single use device.Do not re-sterilize any portion of this device.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." correction: initial reporter name and address.
Event or Problem Description
It was reported that there was a hair found inside the syringe upon opening of the packet.There was no reported patient injury.

• Brand Name: TOOMEY IRRIGATION SYRINGE 70ML WITH CATHETER TIP AND LUER TIP ADAPTERS, PLASTIC,
• Common Device Name: IRRIGATION SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7769826
• Report Number: 1018233-2018-03504
• Device Sequence Number: 1561016
• Product Code: KYZ
• UDI-Device Identifier: 00801741049316
• UDI-Public: (01)00801741049316
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 0038460
• Device Lot Number: NGBV5790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Initial Date Received by Manufacturer: 07/20/2018
• Supplement Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 08/09/2018
• Supplement Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1