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

Catalog Number 0166SI18

Device Problems Inadequate Instructions for Healthcare Professional (1319); Shipping Damage or Problem (1570); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter was in the wrong sterile package.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the catheter was in the wrong sterile package.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.The evaluation confirmed product code printed on box label and pouch paper were printed as 0166sij18 while product code printed on cap of catheter was 0165si18.Based on investigation via dhr review , it is confirmed that this complaint is related to manufacturing.There is a potential of 5cc product (0165sij18 - bardex 2 way male 5cc 18fr, silver lubricious coated catheter) incorrectly packaged into packaging lot mycz1179, 30cc product 0166sij18 (bardex 2 way male 30cc 18fr, silver lubricious coated catheter).The device history record was reviewed and found a possible issue(s) that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿(1)do not reuse.(2)do not resterilize.(3)be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (4)do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1)patients who are or have been allergic to natural rubber latex (2)patients with known allergy to silver-containing catheter".

Event Description

It was reported that the catheter was in the wrong sterile package.

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9309475
• MDR Text Key: 179446932
• Report Number: 1018233-2019-07235
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2023
• Device Catalogue Number: 0166SI18
• Device Lot Number: MYCZ1179
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1