MAUDE Adverse Event Report: MEDITEC DEVICES SUNMED; ET INTRODUCER 9-0212-70

Model Number 9-0212-70

Device Problem Break (1069)

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

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

The reference samples of the lot md163 were checked and none of the pieces broke off or exhibited this tendency.The tensile strength, the parameter related to this problem was checked on one piece from the reference samples and was found to be compliant.Will be able to investigate on receipt of this particular piece.The piece is awaited.

Event Description

The customer says the tip broke off the product.No other details were provided.

• Brand Name: SUNMED
• Type of Device: ET INTRODUCER 9-0212-70
• Manufacturer (Section D): MEDITEC DEVICES; 2a mitul industrial estate; vasai east; palghar, maharashtra 40140 4; IN 401404
• Manufacturer Contact: sajjan paul ; 2a mitul industrial estate; sativali rd, vasai east; palghar, maharashtra 40140-4 ; IN 401404
• MDR Report Key: 9284065
• MDR Text Key: 190775187
• Report Number: 3006389770-2019-00001
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2021
• Device Model Number: 9-0212-70
• Device Lot Number: MD 163
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/02/2018
• 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