MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY; FOLEY CATHETERS

Model Number	782100
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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 device was not returned.
Event or Problem Description
It was reported that the foley package was missing the iodine.The end user stated that she has received many packages without the iodine and no label was provided with any additional details.No medical intervention was reported.
Event or Problem Description
It was reported that the foley package was missing the iodine.The end user stated that she has received many packages without the iodine and no label was provided with any additional details.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event could not be confirmed.It was unknown whether the device met specifications since no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿components / missing accessories¿ with a potential root cause of ¿incorrect operation¿.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubricant.Lubricate catheter.7.Pour cleansing solution onto prep balls.8.Prep patient with saturated prep balls.9.Proceed with catheterization in usual manner.10.If specimen is required, fill sterile container from catheter.11.Top tray may be placed on basin to help prevent spillage.12.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations." 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.

• Brand Name: BARD® FOLEY CATHETERIZATION TRAY URO-PREP¿ TRAY
• Common Device Name: FOLEY CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9977315
• Report Number: 1018233-2020-02688
• Device Sequence Number: 3896402
• Product Code: KNX
• UDI-Device Identifier: 00801741029622
• UDI-Public: (01)00801741029622
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2020

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: Lay User/Patient
• Device Expiration Date: 03/31/2021
• Device Model Number: 782100
• Device Catalogue Number: 782100
• Device Lot Number: NGCU2113
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 04/20/2020
• Supplement Report FDA Received Date: 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1