MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL COUDE URETHRAL CATHETER; TOUCHLESS PLUS W/ COUDE TIP

Catalog Number	4A8116
Health Effect - Clinical Code	Irritation (1941)
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 information provided by bard 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 bard.
Event or Problem Description
It was reported that the coude tip was not as curved as it should be.The device was allegedly difficult to insert and irritation developed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the coude tip was not as curved as it should be.The device was allegedly difficult to insert and irritation developed.
Additional Manufacturer Narrative
Received one unopened touchless catheter for evaluation.During the visual inspection, the eyes and tip of the catheter were inspected for imperfections, rough edges and flash; however, no discrepancy was observed.However, per the dimensional evaluation, the angled tip of the catheter measured 179°.Specification for this product is 165°± 10°.Therefore, the reported event was confirmed as manufacturing related, as the angle of the curve of the catheter was greater than specified.A tactile evaluation was also conducted in which the catheter was slipped through the fingers and no imperfection in the tip and eyes of the catheter were felt.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "male/female catheterization: remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.Slide the catheter halfway into the insertion tip.Male - prepare the male urethral meatus and the surrounding area with povidone-iodine swabs.Female - prepare the female urethral meatus by holding the outer labia apart and prep the urethral meatus and surrounding area with povidone iodine swabs.Male - holding the penis, advance the insertion tip into the urethra no further than the flange base.Female - spread the inner labia, advance the insertion tip into the urethra no further than the flange base.Release the inner labia.Place your non-dominant hand on the finger control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter through bag approximately 1" below the finger control guide and push catheter into urethra.The catheter should be introduced by short, repetitive pushing motions.Repeat motions until catheter reaches bladder and urine starts to flow.Allow urine to flow freely, making certain the catheter guide is elevated at least 4" above lower portion of the bag.Allow flow until bladder is empty or until bag is filled.Precaution: it is recommended that the collection bag be held.The catheter could possibly separate from the collection bag when urine increases weight of the bag.Withdraw the catheter from the urethra.Remove the remaining portion of the catheter from the collection bag by pulling it through the insertion tip.Note: the catheter is designed to pass through the insertion tip securely." (b)(4).
Event or Problem Description
It was reported that the coude tip was not as curved as it should be.The device was allegedly difficult to insert and irritation developed.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL COUDE URETHRAL CATHETER
• Common Device Name: TOUCHLESS PLUS W/ COUDE TIP
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6522921
• Report Number: 1018233-2017-02103
• Device Sequence Number: 11177329
• Product Code: FCM
• UDI-Device Identifier: 00801741046483
• UDI-Public: (01)00801741046483(10)NGWK1424
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/22/2017

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: 12/31/2017
• Device Catalogue Number: 4A8116
• Device Lot Number: NGWK1424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/26/2017
• Supplement Report FDA Received Date: 05/22/2017; 06/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1