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

Model Number	0170SI12
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
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 upon opening the catheter, there was a black spot noticed inside of the hose.It was stated that the black spot was the size of a small dot.The customer did not use the product.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.A coude silicone catheter was returned with its original packaging (include the blue sleeve).Tape was wrapped on the catheter shaft.The tape was removed and a faint black dot was found that was not the black indicator dot.The dot appears to be embedded in the tubing.As per input from moncks corner quality engineering, this is a case of discoloration.The root cause of this failure is operator error in not stirring the tin tank before surface activation due to which there was a visible stain, resulting in discoloration and user dissatisfaction.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Since the reported event is unrelated to labeling, a labeling review is not required.
Event or Problem Description
It was reported that upon opening the catheter, there was a black spot noticed inside of the hose.It was stated that the black spot was the size of a small dot.The customer did not use the product.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9819944
• Report Number: 1018233-2020-01747
• Device Sequence Number: 14138584
• Product Code: MJC
• UDI-Device Identifier: 00801741025327
• UDI-Public: (01)00801741025327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K984136
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2020

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: 05/31/2022
• Device Model Number: 0170SI12
• Device Catalogue Number: 0170SI12
• Device Lot Number: NGBZ2093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 03/11/2020
• Supplement Report FDA Received Date: 04/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1