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

Model Number	897216
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 the foley prematurely deflated after 10 days of use.No medical intervention was required.
Additional Manufacturer Narrative
The reported event was confirmed.The device was used for treatment.Visual evaluation of the sample noted one opened (without original packaging), used dome bag with a sample port connector, drainage tubing, partially filled inflation syringe, silicone foley catheter, and an intact tamper evident seal.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was inflated with methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), but leaked solution from a 0.013" hole in the balloon.There were no missing pieces noted.Balloon pinholes were not permitted.The catheter was confirmed to be 16 fr.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be incorrect jaw fixtures used (leading to overstretching or damaging the balloon).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿this pamphlet is for information only.Only qualified medical personnel may insert a catheter, which is a medical device available through prescription.Remember: 1.Don¿t disconnect, pull on, or twist your catheter or the drainage bag tubing.2.If you notice leaks in the system, notify your nurse immediately.3.Keep the drainage bag below the level of your bladder at all times.Do not place the drainage bag on its side - always keep the bag in an upright position.4.Do not empty the drainage bag yourself.* notify your nurse if the bag becomes full." 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.
Event or Problem Description
It was reported that the foley prematurely deflated after 10 days of use.No medical intervention was required.

• Brand Name: BARD® FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9202552
• Report Number: 1018233-2019-06570
• Device Sequence Number: 11190367
• Product Code: EZL
• UDI-Device Identifier: 00801741020322
• UDI-Public: (01)00801741020322
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 11/04/2019

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: Lay User/Patient
• Device Expiration Date: 04/24/2024
• Device Model Number: 897216
• Device Catalogue Number: 897216
• Device Lot Number: NGDR3391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1