MAUDE Adverse Event Report: TELEFLEX MEDICAL MMG COUDE CATHETER KIT 16; TRAY, CATHETERIZATION, STERILE

Catalog Number RLA-162-3C

Device Problem Sharp Edges (4013)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Customer called stating that his last box of catheters he received have a very point tip.This creates an issue when catheterizing himself.No harm yet.

Manufacturer Narrative

Qn#: (b)(4).The device history record of batch number 74e1902726 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.A visual inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.An attempt to inspect current stock of material was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.No corrective action can be established since the sample is not available to perform an investigation and determine the source of defect reported.If the product sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.

Event Description

Customer called stating that his last box of catheters he received have a very point tip.This creates an issue when catheterizing himself.No harm yet.

• Brand Name: MMG COUDE CATHETER KIT 16
• Type of Device: TRAY, CATHETERIZATION, STERILE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 9558920
• MDR Text Key: 194826429
• Report Number: 3004365956-2020-00010
• Device Sequence Number: 1
• Product Code: FCM
• Combination Product (y/n): N
• PMA/PMN Number: K010420
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

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: Health Professional
• Device Catalogue Number: RLA-162-3C
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/07/2020
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.