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

Model Number	421614
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Patient Problem/Medical Problem (2688)
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 customer received the catheter upside down in the sleeve/package.The customer stated he had a uti from using the product.The customer also stated the packaging seen on the supplier website displayed the tip facing in the correct direction.Per follow up phone call with customer on (b)(6) 2019, they received bactrim ds medication to treat the uti.The customer was to send the unused sample back.
Additional Manufacturer Narrative
The reported event was inconclusive due to the poor sample condition.Visual evaluation of the photo samples noted one opened (partially inside original packaging), clean cath universal catheter.Visual inspection of the sample pictures noted that the catheter appeared to be oriented in the direction opposite of layout drawing.However, because the product was opened, it cannot be determined whether the catheter was packaged incorrectly or not.A potential root cause for the reported 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: "single use: do not resterilize, do not use if package is damaged, caution, consult accompanying documents.".
Event or Problem Description
It was reported that the customer received the catheter upside down in the sleeve/package.The customer stated he had a uti from using the product.The customer also stated the packaging seen on the supplier website displayed the tip facing in the correct direction.Per follow up phone call with customer on (b)(6) 2019, they received bactrim ds medication to treat the uti.The customer was to send the unused sample back.

• Brand Name: BARD® CLEAN-CATH® CATHETER
• Common Device Name: CLEAN CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9364740
• Report Number: 1018233-2019-07495
• Device Sequence Number: 2230506
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 12/30/2019

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: 10/31/2023
• Device Model Number: 421614
• Device Catalogue Number: 421614
• Device Lot Number: NGDS0384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 12/19/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 12/30/2019
• 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: Required Intervention