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

Catalog Number 165816

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)

Event Date 03/17/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard 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 bard.The device was not returned.

Event Description

It was reported that the tubing allegedly broke off/apart.Per additional information: the foley catheter was inserted on (b)(6) 2018.On (b)(6) 2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On (b)(6) 2018, it was further reported that the catheter allegedly broke inside the patient and it was removed.

Manufacturer Narrative

The reported issue (it was reported that the tubing allegedly broke off/apart.(b)(4) was opened on (b)(6) 2018 for the bag.Per additional information: the foley catheter was inserted on (b)(6) 2018.On (b)(6) 2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On 04/05/2018 it was further reported that the catheter allegedly broke inside the patient and it was removed.This record (b)(4) was opened as a result.) was confirmed.During the visual evaluation it was observed that the catheter appeared to be cut off with a sharp object in the drainage arm section, just below the cut section, a torn can be visualized that could have contributed to the reported defect.During the visual evaluation of the retuned device would not observe any stress marks on the breakage site or torn area, the returned catheter was visually evaluated under 10x magnification glass and would not observe any manufacturing deficiencies that would have adversely contributed to the reported problem.Functional evaluation was not conducted due to that the issue reported was confirmed during the visual evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the tubing allegedly broke off/apart.It was later reported that the foley catheter was inserted on (b)(6) 2018.On (b)(6) 2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On 04/05/2018 it was further reported that the catheter allegedly broke inside the patient and it was removed.

Manufacturer Narrative

The reported issue (it was reported that the tubing allegedly broke off/apart.Tw (b)(4) was opened on (b)(6) 2018 for the bag.Per additional information: the foley catheter was inserted on (b)(6) 2018.On (b)(6) 2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On (b)(6) 2018 it was further reported that the catheter allegedly broke inside the patient and it was removed.This record (b)(4) was opened as a result.) was confirmed.During the visual evaluation it was observed that the catheter had the drainage arm broken.No other defects were observed.Functional evaluation was not conducted due to that the issue reported was confirmed during the visual evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.".

Event Description

It was reported that the tubing allegedly broke off/apart.It was later reported that the foley catheter was inserted on (b)(6) 2018.On (b)(6) 2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On (b)(6) 2018 it was further reported that the catheter allegedly broke inside the patient and it was removed.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Corrections: brand name, common device name, concomitant medical products, pma/510k, device evaluated by mfr.

Event Description

It was reported that the tubing allegedly broke off/apart.Per additional information: the foley catheter was inserted on(b)(6)2018.On (b)(6)2018 the foley catheter and cbd (tubing of the bag) allegedly broke off/apart.The foley catheter was removed from the patient.On (b)(6)2018 it was further reported that the catheter allegedly broke inside the patient and it was removed.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7453160
• MDR Text Key: 106408947
• Report Number: 1018233-2018-01346
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 165816
• Device Lot Number: NGBV2972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/23/2018
• Supplement Dates Manufacturer Received: 04/26/2018; 07/02/2018; 08/01/2018
• Supplement Dates FDA Received: 04/27/2018; 07/09/2018; 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1