MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 ROCHESTER HYDRO INTERMITTENT 12 MALE 30BX; INTERMITTENT CATHETER

Model Number	63612
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 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.
Event or Problem Description
It was reported that there was water in the water sachets was insufficient, and the user was unable to activate the lubrication on the catheter.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "how to prepare and use your hydrosil tm catheter for urological use only.Intended for use by patients for bladder management including urine drainage, collection and measurement.The devices are passed to the urinary bladder via the urethra.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/precautions and adverse reactions.This is a single use device.Do not resterilize.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Wash your hands thoroughly with soap and water.Prior to opening the sealed catheter pouch, apply pressure to the foil packet to release the water.Ensure all water is released from the foil packet.Wet the catheter by holding the package with the printed side up and tip the package end-to-end three to six times to wet the catheter.This movement is required so that the water transfers back and forth over the catheter to fully wet the hydrophilic coating.Peel open the pack at the funnel/handle end just enough to expose 5 cm (2¿) of the catheter, or for products with an insertion sleeve, expose the insertion sleeve.Don't remove the catheter yet.Use the adhesive tab at the funnel end of the pack to stick the pack to a nearby vertical surface while preparing to catheterize.Wash the area around the meatus before catheterizing.Wash your hands again.Using the catheter with insertion sleeve (gripper): hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the insertion sleeve with your other hand and slide the insertion sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.Using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Advance the catheter until urine starts to flow.Without insertion sleeve (gripper): hold the handle/funnel end and remove the catheter from the packaging.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.Try to keep the catheter steady until urine stops flowing.When urine stops flowing, slowly withdraw the catheter, stopping if flow starts again, until the last few drops have drained.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water.".
Event or Problem Description
It was reported that there was water in the water sachets was insufficient, and the user was unable to activate the lubrication on the catheter.

• Brand Name: ROCHESTER HYDRO INTERMITTENT 12 MALE 30BX
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• MDR Report Key: 6475708
• Report Number: 1018233-2017-01672
• Device Sequence Number: 1053453
• Product Code: KOD
• UDI-Device Identifier: 00801741069284
• UDI-Public: (01)00801741069284(10)JUAX0657
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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 Expiration Date: 09/30/2021
• Device Model Number: 63612
• Device Catalogue Number: 63612
• Device Lot Number: JUAX0657
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2017
• Supplement Date Received by Manufacturer: 07/31/2017
• Initial Report FDA Received Date: 04/10/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1