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
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 the tip of the plunger came off and therefore the syringe leaked.
Additional Manufacturer Narrative
The reported event was confirmed as supplier related due to the supplier product dimensions being out of specification.The visual evaluation of the returned sample noted 2 tooney syringes, one opened, used syringe without its original packaging, and one unused with a luer tip adaptor (cm50005) inside the barrel, within original packaging.The syringes were filled with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water).The used syringe's tooney adapter (cm1687) outer diameter was 0.2690", which was found out of the specification of 0.250"±0.005", while its inner diameter was 0.1865", which was out of the specification of 0.192"±0.005".The unused syringe's tooney adapter (cm1687) outer diameter was 0.2670" which was out of the specification of 0.250"±0.005", while the tip inner diameter was 0.1885", which was within the specification of 0.192"±0.005".The luer tip adaptor's (cm50005) inner diameter at the larger end was 0.2995", which was found within the specification of 0.303"±0.005".The tip was also measured at the smaller end to be 0.074", which was also within the specification of 0.070".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.".
Event or Problem Description
It was reported that the tip of the plunger came off and therefore the syringe leaked.

• 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: 7850136
• Report Number: 1018233-2018-03974
• Device Sequence Number: 1445785
• Product Code: KYZ
• UDI-Device Identifier: 00801741049316
• UDI-Public: (01)00801741049316
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other,user facili
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 0038460
• Device Lot Number: NGBU0329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Initial Date Received by Manufacturer: 08/17/2018
• Supplement Date Received by Manufacturer: 02/10/2019
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 03/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1