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

Model Number	INTS16
Medical Device Problem Code	Material Too Rigid or Stiff (1544)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the customer recently converted from ureteral catheter tray to intermittent catheter tray and said that the intermittent catheter tray was stiffer and had resulted in patient injury by penetrating the urethra.No medical intervention was reported.
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 the customer recently converted from ureteral catheter tray to intermittent catheter tray and said that the intermittent catheter tray was stiffer and had resulted in patient injury by penetrating the urethra.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be "operator error".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.The instructions for use were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Bard® ez-lok¿ sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip collection devices (fig.1b).Bd vacutainer® urine products can be used for collection, storage, and transport of urine specimens from a urinary catheter.1.Swab surface of bard® ez-lok¿ sampling port with antiseptic (fig.2) e.G., site-scrub¿ ipa device which is an effective disinfecting agent for luer hubs.2.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.(fig.3) 3.If using bd vacutainer® luer-lok¿ access device (fig.4), 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.4.After sample is obtained, discard collection device according to hospital protocol.5.Follow established hospital protocol for specimen labeling and transport to lab".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.

• 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: 14454620
• Report Number: 1018233-2022-03933
• Device Sequence Number: 20418048
• Product Code: KOD
• UDI-Device Identifier: 00801741183225
• UDI-Public: (01)00801741183225
• 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
• Report Date (Section B): 07/18/2022

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: INTS16
• Device Catalogue Number: INTS16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 08/01/2022
• 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