MAUDE Adverse Event Report: BAYLIS MEDICAL COMPANY INC. TORFLEX TRANSSEPTAL GUIDING SHEATH; INTRODUCER, CATHETER

Lot Number	TFFD150323
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis yet; however, the picture provided was evaluated.This is initial mdr to report investigations results (mdr awareness date: 12feb2024).The investigation found that based on photos submitted, packaging is damaged, and integrity of devices is in doubt.A visual inspection was conducted based on the photos submitted, and it was noted that the re-pack shipper identified damaged at one end as well as multiple creases identified overall.Also, a damage has been identified in the caton, the integrity of the device and sterile barrier system is in doubt.The reported allegations are confirmed based on photos submitted with complaint.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a torflex has arrived damaged.It was reported that the packaging and product arrived at the facility damaged; the torflex packaging looked as if it had been folded and had multiple creases down the sleeve; sterile packaging was not compromised.No patient involvement was reported.It was further evaluated during analysis (12feb2024) that based on photos provided, that the packaging is damaged, and integrity of devices is in doubt.A visual inspection was conducted based on the photos submitted, and it was noted that the re-pack shipper identified damaged at one end as well as multiple creases identified overall.Also, a damage has been identified in the caton, the integrity of the device and sterile barrier system is in doubt.

• Brand Name: TORFLEX TRANSSEPTAL GUIDING SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BAYLIS MEDICAL COMPANY INC.; 5959 trans-canada highway; montreal H4T 1 A1; CA H4T 1A1
• Manufacturer (Section G): BAYLIS MEDICAL COMPANY INC.; 5825 explorer drive; mississauga, on L4W 5 P6; CA L4W 5P6
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 18785547
• Report Number: 2124215-2024-08128
• Device Sequence Number: 18230726
• Product Code: DYB
• UDI-Device Identifier: 00685447005414
• UDI-Public: 00685447005414
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K102948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2024
• Device Lot Number: TFFD150323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/12/2024
• Initial Report FDA Received Date: 02/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown