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

Model Number	710014S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.The device was not returned.
Event or Problem Description
It was reported that the patient had the catheter at the hospital and the catheter could not be deflated at all.The catheter had seemed to have curled over or kinked inside and failed to come out.This caused the catheter to be surgically removed and it was so severe that the patient had to be given a suprapubic catheter procedure.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 the patient had the catheter at the hospital and the catheter could not be deflated at all.The catheter had seemed to have curled over or kinked inside and failed to come out.This caused the catheter to be surgically removed and it was so severe that the patient had to be given a suprapubic catheter procedure.
Event or Problem Description
It was reported that the patient had the catheter at the hospital and the catheter could not be deflated at all.The catheter had seemed to have curled over or kinked inside and failed to come out.This caused the catheter to be surgically removed and it was so severe that the patient had to be given a suprapubic catheter procedure.
Additional Manufacturer Narrative
Upon further review, this adverse event is not reportable, as this device is not sold in the u.S.And there is no similar device sold in the u.S.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.

• Brand Name: LATEX FOLEY CATHETER
• Common Device Name: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10444601
• Report Number: 1018233-2020-05405
• Device Sequence Number: 3395551
• Product Code: EZC
• UDI-Device Identifier: 00801741046537
• UDI-Public: (01)00801741046537
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/07/2020

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: Health Professional
• Device Model Number: 710014S
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/31/2020
• Supplement Date Received by Manufacturer: 07/31/2020; 11/18/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 08/25/2020; 12/07/2020
• 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