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

Model Number 0165GL16

Device Problems Break (1069); Incorrect Measurement (1383); Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 upon deflation of the foley catheter, the tip of the catheter was not present and believed to have been broken off inside of the patient.X-ray and cystogram were performed but the tip was not located.Upon receipt of sample, investigators found catheter to be incorrect measurement measuring as an 18fr.

Event Description

It was reported that upon deflation of the foley catheter, the tip of the catheter was not present and believed to have been broken off inside of the patient.X-ray and cystogram were performed but the tip was not located.Upon receipt of sample, investigators found catheter to be incorrect measurement measuring as an 18fr.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.The device measured 18 fr.The specification requires the device measure 16 +/- 1 french.The device did not meet specifications for french size.Potential root causes for the reported issue could be "machine malfunction, operator error, program error, and/or machine fault".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review could not be done as only the manufacturing lot number was given.The catheter is manufactured in moncks and the sent to be placed in single strip packs, trays, and product subassemblies with various labeling.As the corporate lot number or tray product catalog # is not given it is unknown which labeling the user received.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.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8567958
• MDR Text Key: 143681381
• Report Number: 1018233-2019-02238
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741046216
• UDI-Public: (01)00801741046216
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/19/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2023
• Device Model Number: 0165GL16
• Device Catalogue Number: 0165GL16
• Device Lot Number: MCCV3088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 07/01/2019
• Supplement Dates FDA Received: 07/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1