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

Model Number	33416
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
Date of Event	12/28/2018
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 the catheter was allegedly longer than normal, with holes in different spots.Allegedly, the longer length in catheter caused severe bleeding after being in situ for about 10 days.The patient apparently called the nurse who advised hospital assessment, but the patient opted to wait until the morning to visit his/her doctor who allegedly changed the blood thinner medication to help limit the bleeding.It was later noted that the bleeding slowed but didn't stop until a week after the initial conversation.
Additional Manufacturer Narrative
The reported event was inconclusive due to a poor sample.A photo sample of three silastic catheters were returned.The middle catheter appeared to be asymmetric.However, the balloon was not inflated enough to make an adequate determination.As only a photo was returned, we could not determined if the length was out of specifications.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: ¿visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate with stated ml of sterile water.Or ¿ for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.For urological use only.".
Event or Problem Description
It was reported that the catheter was allegedly longer than normal, with holes in different spots.Allegedly, the longer length in catheter caused severe bleeding after being in situ for about 10 days.The patient apparently called the nurse who advised hospital assessment, but the patient opted to wait until the morning to visit his/her doctor who allegedly changed the blood thinner medication to help limit the bleeding.It was later noted that the bleeding slowed but didn¿t stop until a week after the initial conversation.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: SILASTIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8270604
• Report Number: 1018233-2019-00377
• Device Sequence Number: 19257208
• Product Code: EZL
• UDI-Device Identifier: 00801741019982
• UDI-Public: (01)00801741019982
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2019

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 Model Number: 33416
• Device Catalogue Number: 33416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Initial Date Received by Manufacturer: 01/03/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 01/23/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1