MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE; BARD PISTON IRRIGATION TRAY WITH PISTON SYRINGE

Catalog Number	750301
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the patient experienced a bacterial infection in the bladder which was assumed due to the usage of the products.The patient did not like the different supplies provided by the doctor, and reordered from (b)(6).No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive.It was unknown whether the device had met specifications due to no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿materials of construction selected are not biocompatible (bio-incompatible)¿ with a potential root cause of ¿inadequate biological evaluation¿.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "single use only do not reuse do not resterilize sterile: contents of inner wrap are sterile unless package is opened or damaged.Directions for use on reverse side.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Contents: 1 graduated solution container 1 graduated plastic basin 1 waterproof csr wrap 1 piston syringe 1 luer adapter (for foley catheter inflation) caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge." 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the patient experienced a bacterial infection in the bladder which was assumed due to the usage of the products.The patient did not like the different supplies provided by the doctor, and reordered from liberator medical.

• Brand Name: BARD PISTON IRRIGATION TRAY WITH 70ML PISTON SYRINGE
• Common Device Name: BARD PISTON IRRIGATION TRAY WITH PISTON SYRINGE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10106860
• Report Number: 1018233-2020-03510
• Device Sequence Number: 11716498
• Product Code: KYZ
• UDI-Device Identifier: 00801741051104
• UDI-Public: (01)00801741051104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 750301
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other