MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD WOVEN FILIFORM SPIRAL TIP 12.5" (31.75CM) 5 FR., STERILE

Catalog Number	022105
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2019
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 with manipulation during a cystoscopy, the end of the catheter appeared to be flaking off into the bladder.The ureter was still catheterized by dr.(b)(6).No injury noted.
Event or Problem Description
It was reported that with manipulation during a cystoscopy, the end of the catheter appeared to be flaking off into the bladder.The ureter was still catheterized by dr.Dobrochna goberman.No injury noted.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the woven follower catheter is intended for use to dilate the narrowed urethra with woven filiform.It may allow to be used with the stylet for filiform or the foley catheter with tip eyes, if necessary.1.Insert the woven filiform in the bladder.2.Once the filiform has been properly placed in the bladder, attach the woven follower catheter to the filiform.Starting with the smaller size, increase the follower catheter size until the desired dilation is accomplished.3.Detach the woven follower catheter from the filiform, and then leave only the inserted filiform in place.4.Set the stylet for filiform to the foley catheter with tip eyes.5.Attach the tip of the stylet to the filiform placed in.6.Advance the stylet with catheter into the bladder navigation by the filiform.7.The foley catheter with tip eyes is properly placed in the bladder and injected with the sterile distilled water, and then gently remove the stylet.Usage precautions ¿ refer to the package insert and the user's guide for information on the appropriate medical instruments or drugs.".
Event or Problem Description
It was reported that with manipulation during a cystoscopy, the end of the catheter appeared to be flaking off into the bladder.The ureter was still catheterized by dr.(b)(6).No injury noted.
Additional Manufacturer Narrative
The reported event was inconclusive due to an incorrect sample returned.A yellow ureteral catheter was returned instead of the filiform catheter.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the woven follower catheter is intended for use to dilate the narrowed urethra with woven filiform.It may allow to be used with the stylet for filiform or the foley catheter with tip eyes, if necessary.1.Insert the woven filiform in the bladder.2.Once the filiform has been properly placed in the bladder, attach the woven follower catheter to the filiform.Starting with the smaller size, increase the follower catheter size until the desired dilation is accomplished.3.Detach the woven follower catheter from the filiform, and then leave only the inserted filiform in place.4.Set the stylet for filiform to the foley catheter with tip eyes.5.Attach the tip of the stylet to the filiform placed in.6.Advance the stylet with catheter into the bladder navigation by the filiform.7.The foley catheter with tip eyes is properly placed in the bladder and injected with the sterile distilled water, and then gently remove the stylet.Usage precautions ¿ refer to the package insert and the user's guide for information on the appropriate medical instruments or drugs." correction: d4, h3.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.

• Brand Name: BARD WOVEN FILIFORM SPIRAL TIP 12.5" (31.75CM) 5 FR., STERILE
• Common Device Name: BARD WOVEN FILIFORM SPIRAL TIP
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8386671
• Report Number: 1018233-2019-01133
• Device Sequence Number: 19167762
• Product Code: FBW
• UDI-Device Identifier: 00801741073175
• UDI-Public: (01)00801741073175
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2019

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 Catalogue Number: 022105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 05/14/2019; 11/13/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 05/16/2019; 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1