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

Device Problems Biocompatibility (2886); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 193274623
• Report Number: 1018233-2020-03510
• Device Sequence Number: 1
• Product Code: KYZ
• UDI-Device Identifier: 00801741051104
• UDI-Public: (01)00801741051104
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 750301
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other