MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CLEAN-CATH® CATHETER; CLEAN CATH

Model Number	421614
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
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.
Event or Problem Description
It was reported that the catheters were packaged upside down in the packaging which allegedly prevents the patient from inserting the catheter without it being touched.The patient reportedly developed a urinary tract infection.The patient was not prescribed any medication reportedly due to a concern of becoming immune to the medication.
Additional Manufacturer Narrative
The reported event was confirmed as a packaging problem.Visual inspection noted 2 unopened clean catheters received in the original packaging.Neither of the packages were opened, the seal was intact the entire way around.One catheter was sent back for comparison with the tip and eyelet side of the catheter towards the angled tyvek seal, and the second catheter had the tip of the catheter towards the flat tyvek seal of the packaging.A potential root cause for this failure could be 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.This is a single use device.Do not re-sterilize any portion of this device.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 device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.
Event or Problem Description
It was reported that the catheters were packaged upside down in the packaging which allegedly prevents the patient from inserting the catheter without it being touched.The patient reportedly developed a urinary tract infection.The patient was not prescribed any medication reportedly due to a concern of becoming immune to the medication.

• Brand Name: BARD® CLEAN-CATH® CATHETER
• Common Device Name: CLEAN CATH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8624828
• Report Number: 1018233-2019-02634
• Device Sequence Number: 19243439
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 421614
• Device Catalogue Number: 421614
• Device Lot Number: NGCY3202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 05/20/2019
• Supplement Report FDA Received Date: 07/17/2019
• 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