MAUDE Adverse Event Report: COLOPLAST A/S SPEEDICATH COMPACT CH8 FEMALE; INTERMITTENT CATHETER

Model Number 2857801004

Device Problems Device Disinfection Or Sterilization Issue (2909); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

Patient Problem Urinary Tract Infection (2120)

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.A recheck of the product documentation for this lot number did not reveal any norm deviation that could be related to the complaint.Complaints such as this is a new issue with this product line.The complaints are monitored closely for a forming trend and reported to management on a monthly basis.Production has been informed.As we have no received back any samples yet, the necessary tests cannot be made.

Event Description

According to the information received, the mother of a (b)(6) child had learned to perform intermittent catheterization on her daughter at a medical institution.As she had experienced a second time the speedicath catheter was dry and she feared the catheter was non-sterile and she suggested her daughter had got a urinary tract infection (uti) some time ago, caused by the catheter.The mother stated she would engage a lawyer as she had received catheters with the lot numbers for the second time from the distributor even though she had informed about the uti suffered some time ago.The medical institution was asked the mother to call coloplast to provide further information about the circumstances, outcome of the child and treatment.Additional information received reported that the first infection occurred 2-3 months ago (exact date not available).The child again had a uti, diagnosed by the doctor.The child did not take medicine to treat the infection, but the next week the urine would be examined again.The doctor would then decide if medicine would be needed.The mother feared the actual infection was caused by the speedicath compact of the reported lot number, as she had used catheters of this lot number previously.Additional information received from the mother reported that the child still had an infection but no fever, so the doctor had decided to not prescribe medicine.It was noted that the family had several health problems (both children were ill and the father would be operated next week).They did not talk to the health insurance yet and they were still undecided whether they would engage a lawyer or not.Additional information received from the mother reported that she assumed that the catheters must have been dried out because they extended only a short length.

• Brand Name: SPEEDICATH COMPACT CH8 FEMALE
• Type of Device: INTERMITTENT CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, DK-30 50; DA DK-3050
• Manufacturer (Section G): COLOPLAST A/S NYIRBATOR HUNGARY; coloplast a/s nyirbator; coloplast utca 2; 4300 ; HU 4300
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5943753
• MDR Text Key: 54823755
• Report Number: 3006606901-2016-00030
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• PMA/PMN Number: K072808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2857801004
• Device Catalogue Number: 2857801004
• Device Lot Number: 5183558
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/22/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 12 MO