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

Catalog Number 0165SI14

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/01/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the customer emailed in after buying a foley catheter privately from the representative due to having issues with bullens sending faulty catheters.Stated that the foley catheters were normally 26 cm in length.The last 10 catheters the patient had received were only about 20cm.The patient called the representative and confirmed that they haven't changed the length and the catheters were still 26cm.However after buying catheter from the representative, it was found that the size of the catheter was 20cm.

Manufacturer Narrative

The reported event is confirmed-manufacturing related.Based on photo, it was confirmed that the length of female foley catheter was 8¿ instead of 11¿.Preliminary investigation have confirmed that 11¿ female foley catheters are being produced as 8¿ regular length female foley catheters.A potential root cause due to inadequate procedure guideline during product transfer.A device history record review was not required.A labeling review is not required it is confirmed as unrelated to the labeling issue.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 actual/suspected device was inspected.

Event Description

It was reported that the customer emailed in after buying a foley catheter privately from the representative due to having issues with bullens sending faulty catheters.Stated that the foley catheters were normally 26 cm in length.The last 10 catheters the patient had received were only about 20cm.The patient called the representative and confirmed that they haven't changed the length and the catheters were still 26cm.However after buying catheter from the representative, it was found that the size of the catheter was 20cm.

Event Description

It was reported that the customer emailed in after buying a foley catheter privately from the representative due to having issues with bullens sending faulty catheters.Stated that the foley catheters were normally 26 cm in length.The last 10 catheters the patient had received were only about 20cm.The patient called the representative and confirmed that they haven't changed the length and the catheters were still 26cm.However after buying catheter from the representative, it was found that the size of the catheter was 20cm.

Manufacturer Narrative

The reported event is confirmed-design related.Evaluation on returned sample confirmed that the length of female foley catheter was 8¿ instead of 11¿.Preliminary investigation have confirmed that 11¿ female foley catheters are being produced as 8¿ regular length female foley catheters at the malaysia facility.The 11¿ female length catheters were inadvertently transferred to the malaysia plant during the journey project as 8¿ catheters.Potential root cause due to inadequate procedure guideline during product transfer.A device history record review was not required.A labeling review is not required it is confirmed as unrelated to the labeling issue.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.

• 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
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17571875
• MDR Text Key: 322275167
• Report Number: 1018233-2023-06164
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165SI14
• Device Lot Number: NGHN4359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other