MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER; STRAIGHT CATHETER KIT

Model Number	772414
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.
Event or Problem Description
It was reported that a straight catheter kit had missing providone-iodine swabs.Another kit was obtained that also had missing providone-iodine swabs, and both kits had the same lot number.Both kits were discarded and another was obtained with no harm to the patient.
Additional Manufacturer Narrative
The device was not returned for evaluation.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: ¿red rubber catheter, 15 fr., preconnected to closed system collection bag (1000ml approx.Vol.) uro-prep¿ tray with: underpad, drape sterile: contents of inner wrap are sterile unless package is opened or damaged.C.R.Bard, inc.Covington, ga 30014 1-800-526-4455 www.Bardmedical.Com povidone-iodine swabsticks (3) specimen container and label graduated collection container synthetic vinyl gloves (2) lubricant packet" 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 a straight catheter kit had missing providone-iodine swabs.Another kit was obtained that also had missing providone-iodine swabs, and both kits had the same lot number.Both kits were discarded and another was obtained with no harm to the patient.

• Brand Name: BARD® URETHRAL CATHETERIZATION TRAY WITH RED RUBBER CATHETER
• Common Device Name: STRAIGHT CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8896979
• Report Number: 1018233-2019-04741
• Device Sequence Number: 18958360
• Product Code: KOD
• UDI-Device Identifier: 00801741030406
• UDI-Public: (01)00801741030406
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2019

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: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: 772414
• Device Catalogue Number: 772414
• Device Lot Number: NGCV1239
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 08/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR