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

Model Number	0165GL16
Medical Device Problem Code	Incorrect Measurement (1383)
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 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 or Problem 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.
Additional 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
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8567958
• Report Number: 1018233-2019-02238
• Device Sequence Number: 2191457
• Product Code: EZC
• UDI-Device Identifier: 00801741046216
• UDI-Public: (01)00801741046216
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 04/09/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1