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

Catalog Number	INTAAI
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that urine stayed in the foley catheter tube during straight catheterization therefore customer could not tell when their bladder was done draining as urine remained in the tube.Bladder scanned patient for 900cc and got out 600cc of urine.Waited for prolonged amount of time to see if anymore urine would drain but could not tell when bladder was finished draining since urine sat stagnant in the foley.
Additional 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.H3 other text : 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 ¿design same as predicate¿.The dhr review could not be performed without a lot number.The instructions for use were found adequate and state the following: "proper techniques for urinary catheter insertion: perform hand hygiene immediately before and after insertion.Insert urinary catheters using aseptic technique and sterile equipment.Use the smallest catheter possible, consistent with good drainage.Document the indications for catheter insertion, date and time of catheter insertion, and individual who inserted catheter.Indications for use: for urological use only.Silicone: intended for use for bladder management including urine drainage, collection and measurement.The devices are generally passed to the urinary bladder via the urethra.Swab surface of bard® ez-lok¿ sampling port with antiseptic e.G., site-scrub¿ ipa device which is an effective disinfecting agent for luer hubs.Using aseptic technique, position the collection device in the center of the sampling port.Press the device firmly and twist gently to access the sampling port.If using bd vacutainer® luer-lok¿ access device, collect urine into the bd vacutainer® tubes per hospital protocol.If using syringe, slowly aspirate urine sample into syringe and transfer to collection cup or follow hospital protocol.After sample is obtained, discard collection device according to hospital protocol.Follow established hospital protocol for specimen labeling and transport to lab.Single use only.Do not resterilize.For urological use only." 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 urine stayed in the intermittent catheter tube during straight catheterization therefore customer could not tell when their bladder was done draining as urine remained in the tube.Bladder scanned patient for 900cc and got out 600cc of urine.Waited for prolonged amount of time to see if anymore urine would drain but could not tell when bladder was finished draining since urine sat stagnant in the foley.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18192804
• Report Number: 1018233-2023-08458
• Device Sequence Number: 15088580
• Product Code: OHR
• UDI-Device Identifier: 00801741183317
• UDI-Public: (01)00801741183317
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: INTAAI
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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: Required Intervention
• Patient Sex: Unknown