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

Catalog Number 0165SI16

Device Problems Partial Blockage (1065); Incorrect Measurement (1383)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 06/03/2021

Event Type  Injury  

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 customer advised, the internal and external diameter of foley catheter had a fluctuation which was putting patient risk of autonomic dysreflexia.Patient was on the verge of being unconscious.Due to blocked catheters, they swifted the foley catheter and gtn (glyceryl trinitrate) spray.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "program error or operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because labeling could not have prevented the reported failure.H11: section a through f - the information provided by bd represents all 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.H3 other text: the device was not returned.

Event Description

It was reported that the customer advised, the internal and external diameter of foley catheter had a fluctuation which was putting patient risk of autonomic dysreflexia.Patient was on the verge of being unconscious.Due to blocked catheters, they swifted the foley catheter and gtn (glyceryl trinitrate) spray.Per follow up via ibc on (b)(6) 2021, the blockage was a smaller hole than normal on the catheter.

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 12071861
• MDR Text Key: 258971251
• Report Number: 1018233-2021-03824
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2023
• Device Catalogue Number: 0165SI16
• Device Lot Number: NGEW2105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/03/2021
• Initial Date FDA Received: 06/25/2021
• Supplement Dates Manufacturer Received: 08/31/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention