MAUDE Adverse Event Report: ROCHESTER MEDICAL CORP 2130787 ROCHESTER HYDROSIL INTERMITTENT WITH GRIPPER 14CH MALE 30BX; ISC

Catalog Number 73614

Device Problems Moisture or Humidity Problem (2986); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.The device was not returned.

Event Description

It was reported that the patient called to place an order, and while doing so advised that he was having trouble with the catheters, as they are lacking lubrication.Therefore, he was using more and has to keep throwing them away because they could not be used.He said this had only occurred since the change of the packaging.

Manufacturer Narrative

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 states the following: "how to prepare and use your hydrosiltm 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." (b)(4).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.The device was not returned.

Event Description

It was reported that the patient called to place an order, and while doing so advised that he was having trouble with the catheters, as they are lacking lubrication.Therefore, he was using more and has to keep throwing them away because they could not be used.He said this had only occurred since the change of the packaging.

• Brand Name: ROCHESTER HYDROSIL INTERMITTENT WITH GRIPPER 14CH MALE 30BX
• Type of Device: ISC
• Manufacturer (Section D): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer (Section G): ROCHESTER MEDICAL CORP 2130787; one rochester medical dr.; stewartville MN 55976
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6518485
• MDR Text Key: 73800071
• Report Number: 1018233-2017-02017
• Device Sequence Number: 1
• Product Code: KOA
• UDI-Device Identifier: 00801741069635
• UDI-Public: (01)00801741069635
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K000723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 06/13/2017

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 73614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2017
• Initial Date FDA Received: 04/25/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1