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

Model Number	INTS14C
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
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.The device was not returned.
Event or Problem Description
It was reported that surestep intermittent catheter kits were leaking.
Additional Manufacturer Narrative
The reported event was confirmed by capa association as design related issue.No sample was returned for evaluation.The device history record review was not required as the complaint was addressed by existing capa.A dhr review was not required because the investigation was confirmed to not be manufacturing related.A labeling review was not required as the complaint was addressed by existing capa.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 or Problem Description
It was reported that surestep intermittent catheter kits were leaking.

• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12519372
• Report Number: 1018233-2021-05902
• Device Sequence Number: 16422275
• Product Code: KOD
• UDI-Device Identifier: 00801741183232
• UDI-Public: (01)00801741183232
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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: Lay User/Patient
• Device Model Number: INTS14C
• Device Catalogue Number: INTS14C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/31/2021
• Supplement Date Received by Manufacturer: 03/15/2022
• Initial Report FDA Received Date: 09/23/2021
• Supplement Report FDA Received Date: 04/10/2022
• 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