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

Catalog Number 0165L14

Device Problems Material Fragmentation (1261); Device Handling Problem (3265)

Patient Problems Foreign Body In Patient (2687); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/11/2023

Event Type  Injury  

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 foley catheter rupture occurred due to self-extraction by patient.The tip was retrieved by a urologist.As per information mentioned in the internal bd comments based on the visual inspection result at japan pir lab on (b)(6) 2023, they confirmed that the catheter was disconnected.The colors were different, but when they put the cross sections together, they matched 360 degrees.They discarded the inlet tube and bag.Per mail received on 14dec2023, it was confirmed from the sales representative that a part of the catheter was remained in the patient and was removed by the doctor.

Manufacturer Narrative

Photograph, video and/or physical sample evaluation: no photograph associated with this case was received.No return sample has been received for this complaint.Batch record revision results: lot 3e01184 was manufactured on 05 may 2023, in mlk-3 line, with a total of (b)(4) market units (mkus).The complaint investigator performed a batch record review on 29/dec/2023, to verify if all the applicable procedures were followed and no issues were found; all the components for assembly were correct per bill of materials (bom) and all the tooling information documented was also correct, system application product (sap) material identification (id) 1051281 and manufacturing order 1691902.The production process, in-process control, testing results and packaging of products was run according to the process instruction.Review of the batch records showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements.No discrepancy related to this issue were found within the documentation.Historical complaints review: on 29/dec/2023, complaint investigator ran a query in database in order to verify the complaints reported for the lot 3e01184 for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ and as result no additional type 2 complaint were identified during this search as per work instructions (wi).Historical nonconformance review: on 29/dec/2023, complaint investigator ran a query in database looking for any in process nonconformance / corrective action / preventive actions (capa) (s) associated to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿ for the lot number 3e01184 and as result, no nonconformance / corrective action / preventive actions (capa) (s) for this malfunction code were generated during the manufacturing process of the referenced lot.Current quality controls: based on the process instruction (pi), the following tests are performed in the manufacturing lines, in order to identify this failure mode in our manufacturing process: test methods (tm-001) " flange weld integrity - adhesive wafers" ¿ method 13 frequency: hourly.Sample quantity: 6.Acceptance criteria: accept = 0 | reject = 1.Defect rate analysis: there have only been 11 defective parts confirmed to date from a lot size of 16,400 products.This represents a defect rate of only 0.067% which is well within an appropriate acceptable quality level (aql) for leakage which should be 0.25% based on our standard operating procedure (sop).In addition, all the in-process testing on this lot did not find a single defective unit, which confirms that the lot is unlikely to breach an acceptable quality level (aql) of 0.25.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.Conclusions: the review of the batch record 3e01184 showed that all relevant tests required during the manufacturing process and final product release had been fulfilled and met the requirements, all applicable manufacturing and quality processes were followed, and no discrepancies or deviations were recorded.No nonconformity has been registered during the manufacturing process of the affected lot for the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.One additional complaint was reported for lot affected related to the malfunction code ¿skin barrier starter hole is defective (e.G misalignment or off center), leakage may occur (pre-cut only)¿.Based on this, no negative trend was identified.Based on preliminary investigation results, there is no objective evidence that other products from this lot are impacted.This issue certainly appears to be an isolated incident, but more importantly to date, it is well within our accepted acceptable quality level (aql) level for this type of failure mode or defect.This issue will be monitored through the post market product monitoring review process.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number: reporting site: 1049092, manufacturing site: 9618003.

Event Description

It was reported that the foley catheter rupture occurred due to self-extraction by patient.The tip was retrieved by a urologist.As per information mentioned in the internal bd comments based on the visual inspection result at japan pir lab on 13dec2023, they confirmed that the catheter was disconnected.The colors were different, but when they put the cross sections together, they matched 360 degrees.They discarded the inlet tube and bag.Per mail received on 14dec2023, it was confirmed from the sales representative that a part of the catheter was remained in the patient and was removed by the doctor.

• Brand Name: BARDEX® LUBRICATH® 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: 18393469
• MDR Text Key: 331317418
• Report Number: 1018233-2023-09190
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0165L14
• Device Lot Number: MYHU0715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2023
• 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; Required Intervention