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

Model Number	INTP16
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
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.
Event or Problem Description
It was reported that the intermittent catheter was not firmly attached to the bag and came apart very easily.Stated that it came apart during one time while catheterizing the patient and tried to lower the bag so they could see if it had stopped draining.They predicted that their staff would just disconnect the bag from the catheter and let the urine drain into the tray provided, completely negating the goal of a closed system.Also stated that they personally tried the catheter three different times, the 14 fr twice and the 16 fr once.They did not notice a faster flow in either but did like the firmness of the catheter and felt it inserted around the infant's head easier.But sadly they did have the catheter disconnect from the bag very easily while trying to get it to flow better and as suspected, urine all over the bed.There were 10 catheters affected from each tray.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be" incorrect assembly operation ".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: "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: pvc & red rubber: 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 bard® ez-lok¿ sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip collection devices.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 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.3.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.4.After sample is obtained, discard collection device according to hospital protocol.5.Follow established hospital protocol for specimen labeling and transport to lab.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.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." h11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the intermittent catheter was not firmly attached to the bag and came apart very easily.Stated that it came apart during one time while catheterizing the patient and tried to lower the bag so they could see if it had stopped draining.They predicted that their staff would just disconnect the bag from the catheter and let the urine drain into the tray provided, completely negating the goal of a closed system.Also stated that they personally tried the catheter three different times, the 14 fr twice and the 16 fr once.They did not notice a faster flow in either but did like the firmness of the catheter and felt it inserted around the infant's head easier.But sadly they did have the catheter disconnect from the bag very easily while trying to get it to flow better and as suspected, urine all over the bed.There were 10 catheters affected from each tray.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: INTERMITTENT CATHETER
• 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: 14622174
• Report Number: 1018233-2022-04444
• Device Sequence Number: 4509385
• Product Code: KOD
• UDI-Device Identifier: 00801741183300
• UDI-Public: (01)00801741183300
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• 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): 11/14/2022

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: INTP16
• Device Catalogue Number: INTP16
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/20/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 11/16/2022
• 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