MAUDE Adverse Event Report: OSCOR INC. SAFESHEATH® II DYB

Model Number SS8

Device Problem Material Too Rigid or Stiff (1544)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Conclusion not yet available, evaluation in process. A follow-up will be submitted as soon as the investigation is complete.

Event Description

It was reported the sheath did not split all the way down to the tip of the sheath, instead the peel along the longitudinal axis was incomplete. The split had to be completed by either cutting or grasping the material with a clamp. No patient adverse effects were reported.

• Brand Name: SAFESHEATH® II
• Type of Device: DYB
• Manufacturer (Section D): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC.; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: doug myers ; 3816 desoto blvd.; palm harbor, FL 34683 ; 7279372511
• MDR Report Key: 12229218
• Report Number: 1035166-2021-00079
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 30891492002235
• UDI-Public: 30891492002235
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: SS8
• Device Catalogue Number: SS8
• Device Lot Number: DP12240
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sex: No Answer Provided
• Patient Weight: KG