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

Model Number	INTS14
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer experienced issues with the ss intermittent straight tip catheter.They said that unless the bladder was super full, the urine would not flow, and it was hard to tell when the bladder had been drained because it appeared stuck at the outlet.To their knowledge, they did not think that there had been any patient harm caused, but they could not say for sure.To work around this, they had been cutting the bag off and draining it into a basin instead.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: b, d, g 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.The device was not returned.
Event or Problem Description
It was reported that the customer experienced issues with the surestep intermittent straight tip catheter.They said that unless the bladder was super full, the urine would not flow, and it was hard to tell when the bladder had been drained because it appeared stuck at the outlet.To their knowledge, they did not think that there had been any patient harm caused, but they could not say for sure.To work around this, they had been cutting the bag off and draining it into a basin instead.Per additional information received via email on 15jun2022, they had concerns that the bladders might not have been emptied fully.It was stated that they only had ints14 intermittent catheterization, so they could not check with a different intermittent catheter.
Event or Problem Description
It was reported that the customer experienced issues with the ss intermittent straight tip catheter.Customer stated that unless the bladder was super full, the urine would not flow, and it was hard to tell when the bladder had been drained because it appeared to be stuck at the outlet.Customer did not think that there had been any patient harm caused, but they weren't sure.Customer stated that to work around this, they had been cutting the bag off and draining it into a basin instead.Per additional information received via email on 15jun2022, stated that they had concerns that the bladders might not have been emptied fully.Stated that they only had ints14 intermittent catheterization so they could not check with a different intermittent catheter.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "kinked or partially collapsed drainage lumen".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.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: 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: 14756408
• Report Number: 1018233-2022-04786
• Device Sequence Number: 1334388
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/04/2022
• 2 Devices were Involved in the Event: 1 2

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: INTS14
• Device Catalogue Number: INTS14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/01/2022
• Supplement Date Received by Manufacturer: 06/15/2022; 08/04/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/05/2022; 08/17/2022
• 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