MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 8813793009

Device Problems Break (1069); Material Frayed (1262); Misassembled (1398); Product Quality Problem (1506); Defective Component (2292); Tear, Rip or Hole in Device Packaging (2385); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the product was of lower quality material, crumpled (crimped) guide wire.Some guides were thicker than the tip of the catheter and they need to force it.The catheter broke on the second day of use (fracture), or broke the tips during introduction.The guide tip did not fit the needle.There was a low flow from the second day of use.The guide was too flexible and hindered tunneling.The internal volume of sets was smaller than other catheters.The catheter was too soft, making insertion difficult in obese patients or patients with subcutaneous fibrosis.The thinner dilator had no consistency and did not act as a dilator in patients with more skin or subcutaneous resistance.The set of complaints above led to the low durability of the catheter, generating the need for frequent change and impairing the performance of the sessions, as well as the need to use heparin in all sessions, which many services dispute.The kit was without blade and syringe.Puncture needle did not seal when connected to syringe, with air inlet.The box had no lid, it came closed with a micropore.There was a bad cover that was broken and came loose from the silicone connection.Fragile packaging.Thermosensitive catheter material, which led to catheter deformation with body temperature alone.There was no patient outcome.

Manufacturer Narrative

Correction: b5 additional information: g3 medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the product was of lower quality material, crumpled (crimped) guide wire.Some guides were thicker than the tip of the catheter and they needed to force it.The catheter broke on the second day of use (fracture) or broke the tips during introduction.The guide tip did not fit the needle.There was a low flow from the second day of use.The guide was too flexible and hindered tunneling.The internal volume of sets was smaller than the other catheter.The catheter was too soft, making insertion difficult in obese patient or patient with subcutaneous fibrosis.The thinner dilator had no consistency and did not act as a dilator in patient with more skin or subcutaneous resistance.The set of complaint above led to the low durability of the catheter, generating the need for frequent change and impairing the performance of the session, as well as the need to use heparin in all session, which many services dispute.The kit was without blade and syringe.Puncture needle did not seal when connected to syringe, with air inlet.The box had no lid; it came closed with a micropore.There was a bad cover that was broken and came loose from the silicone connection.Fragile packaging.Thermosensitive catheter material, which led to catheter deformation with body temperature alone.There was no patient outcome.

• Brand Name: MAHURKAR
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer (Section G): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101 ; CS 20101
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12590669
• MDR Text Key: 275218341
• Report Number: 3009211636-2021-00282
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10884521004801
• UDI-Public: 10884521004801
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K943349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8813793009
• Device Catalogue Number: 8813793009
• Device Lot Number: 2023800093
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2021
• Date Device Manufactured: 09/26/2020
• 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