MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5.2+ JL3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 533551

Device Problems Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the manufacturing documentation associated with this lot 17671586 presented no issues during the manufacturing process that can be related to the reported complaint.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when opening the blister the cath f5.2+ jl3.5 100 cm was split which may have led to an aseptic risk.No patient injury reported and the product will be returned for analysis.Additional information has been requested.

Manufacturer Narrative

The following sections have been updated accordingly: b5, d10, g4, g7, h1, h3, h6, h10.As reported, when opening the blister the cath f5.2+ jl3.5 100 cm was split which may have led to an aseptic risk.No patient injury reported.Multiple attempts were made without success to obtain additional information and product return.The product was not returned for analysis.A device history record (dhr) review of lot 17671586 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box frayed/split/torn - inner package¿ and ¿packaging/pouch/box compromised sterility¿ could not be confirmed as the device was not returned for analysis.The exact cause could not be determined.Based on the limited information available for review, storage and handling factors may have contributed to the reported event.According to the instructions for use, which is not intended as a mitigation, ¿do not use if package is open or damaged.¿ neither the dhr nor the information available suggests a design or manufacturing related cause for the reported event.Therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, when opening the blister the cath f5.2+ jl3.5 100 cm was split which may have led to an aseptic risk.No patient injury reported and the product will not be returned for analysis.Multiple attempts were made without success to obtain additional information and product return.

• Brand Name: CATH F5.2+ JL3.5 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014 ; MX 33014
• MDR Report Key: 7251032
• MDR Text Key: 99336418
• Report Number: 9616099-2018-01832
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K862244
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 533551
• Device Lot Number: 17671586
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening