MAUDE Adverse Event Report: VERICEL MACI; CARTILAGE BIOMATRIX IMPLANT

Model Number 81074

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Maci comar dish leak [product complaint].Case description: case reference number (b)(4) is a spontaneous pqc (product quality complaint) case initially received from a customer care representative on (b)(6) 2019 regarding maci comar dish leaking.On (b)(6) 2019, the area sales director at vericel noticed that media had leaked out of the maci comar dish in transit (lot no: bb10610, exp.Date: 01-jan-2020).The reporter clarified that the leak seemed substantial as fluid was seen in the 95kpa bag and collected by the absorbent sheet.The surgery was not moved forward and the membranes were sent back to vericel.Continued in additional info section on 06-jan-2020, the quality control sterility test was performed and results of pre-release sample type qc2-113 was passed and sterility test results of the final product sample type qc2-113 were also reported as passed.Environmental results included personnel monitoring of manufacturing which had passed with grade a parameters and personnel monitoring of qc sterility which had passed with grade a parameters as well.The quality control assay was reviewed which included qc2-132 cell viability, qc2-140 mycoplasma assay, qc2-133 potency assay and qc2-135 endotoxin assay.All were reported as passed.Additional information received on 06-jan-2020 included quality check results and is blended in the case narrative above.No adverse event was reported.No further information was provided.

• Brand Name: MACI
• Type of Device: CARTILAGE BIOMATRIX IMPLANT
• Manufacturer (Section D): VERICEL; 64 sidney street; cambridge MA 02139
• Manufacturer Contact: 64 sidney street; cambridge, MA 02139
• MDR Report Key: 9635944
• MDR Text Key: 221299478
• Report Number: 3002836339-2020-00001
• Device Sequence Number: 1
• Product Code: NCO
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: 125603
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: 81074
• Device Lot Number: BB10610
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1