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

Model Number	365718
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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.
Event or Problem Description
It was reported that the balloon on the foley catheter would not deflate with the syringe.The complainant reported that they ended up cutting the tip off for the balloon to deflate.
Event or Problem Description
It was reported that the balloon on the foley catheter would not deflate with the syringe.The complainant reported that they ended up cutting the tip off for the balloon to deflate.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition, since inflation and deflation could not be tested.The device was used for treatment and it was unknown if the product was within specification or influenced by the failure due to the poor sample condition.Visual evaluation of the sample noted one used two-way silicone foley without original packaging.It was noted that the inflation arm was cut off, so inflation and deflation of the catheter could not be tested.The balloon was dissected to examine if the inflation notch and the perforation was noted to be complete, meaning that this could not have caused failure to a deflate.A potential root cause for this reported failure could be tooling misalignment.The lot number is unknown; therefore, a device history record could not be reviewed.A labeling review cannot be completed due to no product catalog number provided.Correction: brand name, common device name, pma/510k.

• Brand Name: ALL SILICONE CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9271998
• Report Number: 1018233-2019-07002
• Device Sequence Number: 14287257
• Product Code: EZL
• UDI-Device Identifier: 00801741077753
• UDI-Public: (01)00801741077753
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2019

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: 365718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 11/14/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1