MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP INTERMITTENT CATHETER TRAY

Model Number	INTS14
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the silicone intermittent catheter were becoming disconnected during draining and nurse stated that the catheter was not being attached at all when they opened the package.It was also stated that the customer has observed the same with the pvc intermittent catheters.Also, nurse could not figure out how to empty the leg bag as they did not want to throw full bag of urine in the garbage, and it had occurred with two different nurses.The bag and the catheter were not together, so the nurse emptied the bladder with the catheter and collected it in the procedure tray.While the nurse had the catheter in the bladder draining urine, the leg bag came off the catheter in the middle of the procedure.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "components out of specification".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.A labeling review was not performed 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 or Problem Description
It was reported that the silicone intermittent catheter were becoming disconnected during draining and nurse stated that the catheter was not being attached at all when they opened the package.It was also stated that the customer has observed the same with the pvc intermittent catheters.Also, nurse could not figure out how to empty the leg bag as they did not want to throw full bag of urine in the garbage, and it had occurred with two different nurses.The bag and the catheter were not together, so the nurse emptied the bladder with the catheter and collected it in the procedure tray.While the nurse had the catheter in the bladder draining urine, the leg bag came off the catheter in the middle of the procedure.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: INTERMITTENT CATHETER TRAY
• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14843380
• Report Number: 1018233-2022-04968
• Device Sequence Number: 14041136
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2022

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 Model Number: INTS14
• Device Catalogue Number: INTS14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 10/25/2022
• Initial Report FDA Received Date: 06/28/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown